is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality &
Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
The Quality & Compliance Senior Specialist I works closely with c GMP groups throughout the facility in order to perform internal audits, and to client audits and regulatory inspections. The Senior Specialist I also works directly with clients to support audits and inspections, as well as to develop process validation documents to support the client project moving from clinical to commercial. The Quality & Compliance team is responsible for ensuring the site remains regulatorily compliant and always inspection
ready. This is a full-time on-site salaried position, Monday - Friday 8:00am to 5:00pm Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role: Oversees the internal audit program, including coordinating the audit with relevant department subject matter experts, performing in-depth backssments of systems and procedures; communicating audit findings to key stakeholders; assisting with the development and review of audit responses Oversees the customer audit program, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions Monitors and backsses changes to regulatory guidance and compendial monographs Provides support to ensure that the quality systems are maintained in compliance with regulatory and customer requirements as well as corporate requirements.
Supports and enhances effectiveness of the quality system, including developing and reporting metrics; developing and authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Drafts, reviews, executes, and approves technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.
g. PPQ, CPV, APR / PQR) All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 7 years related experience, OR Master's Degree in STEM discipline with minimum of 10 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 15 years related experience, OR Associate's Degree in STEM discipline with minimum of 17 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to xyz X@.
This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U. S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U. S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
a member of the leadership team at the facility. Activities desired in your role as a member of the leadership team are safety audits, quality, process improvement initiatives, employee training, and upgrading your employees and your own current skills. ESSENTIAL DUTIES AND RESPONSIBILITIES Promotes and adheres to company safety work rules and regulations.
Oversees and assures that all duties and responsibilities performed by Quality Control Technicians, Quality Control Leads, Quality Control Coordinator, and Bacteria Technician are performed accurately and in compliance with established procedures. Researches and answers customer complaints as requested by QA Manager. Prepares product
cuttings as requested by the QA Manager. Prepares data collection as requested by the QA Manager. Prepares and conducts safety meetings on monthly basis. Assures product in Hold Status is analyzed for final dispensation by the QA Manager.
Collects and prepares monthly department reports. Communicates any problems or changes in department to supervisor and appropriate personnel. Attends and participates in all annual, departmental, and job specific required training and monthly informational meetings. Understands and adheres to the concepts and techniques of the quality process in order to ensure a quality operation. Keeps area clean and orderly in accordance with Good Manufacturing Practices
(GMP’s). Helps to build and promote a strong “Teamwork” environment in each individual work group, the Factory, and the Company.
Participates in continuous improvement process. SUPERVISORY RESPONSIBILITIES Directly supervises employees in the Quality Control lab. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Managers and supervisors are responsible for cultivating employee attitudes favorable towards Affirmative Action Programs.
They have a key responsibility for following organizational policies, ensuring everyone equal employment opportunity, and making decisions that affect the progress toward achieving our affirmative action goals. SCOPE OF AUTHORITY Authority to hold product for food safety or quality standard violations. Authority to schedule and edit time for QC employees. Authority to hire and discipline employees in consultation with the QA Manager and Human Resources. Authority to enforce Mc Cain policies and procedures. Responsibility to monitor work areas, watch for suspicious behavior and report any concerns regarding unidentified visitors and/or unauthorized personnel.
Authority to question and take appropriate measures regarding the safety of themselves, other employees, products, and equipment. Responsibility of maintaining a high standard of cleanliness throughout the food processing facility, especially where any raw or finished product is produced. Authority to report and/or eliminate hazards to the safety of the food that is produced in the facility. REQUIRED TRAINING Mc Cain Safety Policy/Accident Reporting Annual HACCP/GMP’s Training Annual interactionual Harassment Awareness Training Plant Emergency Evacuation Training/Emergency Response Statistical Process Control (SPC) Right-To-Know Lockout-Tag out Ladder Safety Fall Protection/PPE’s Confined Space Hot Work Blood-borne Pathogens Key-Element Training Crisis Management MQP Training Other Training as Required QUALIFICATION REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE Associate Degree in Food Science or Business and/or 2 years related Q. C. or Supervisory experience. Microbiology experience preferred, along with potato processing experience. CERTIFICATES, LICENSES, and REGISTRATIONS First Aid/CPR Certified LANGUAGE SKILLS Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. REASONING ABILITY Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
OTHER SKILLS AND ABILITIES Computer Skills (Excel, Access, Word, Outlook, AS 400). Phone Skills. Verbal and Written Communication Skills. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk, sit, use hands to finger, handle, or feel objects, tools, or controls and talk or hear.
The employee frequently is required to stand, and taste or smell. The employee is occasionally required to; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 36 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles. The employee frequently works near moving mechanical parts. The employee occasionally works in outside weather conditions and is occasionally exposed to risk of electrical shock and vibration. The noise level in the work environment is usually loud. Mc Cain Foods is an equal opportunity employer.
We see value in ensuring we have a diverse, antiracist, inclusive, merit-based, and equitable workplace. As a global family-owned company we are proud to reflect the diverse communities around the world in which we live and work. We recognize that diversity drives our creativity, resilience, and success and makes our business stronger. Mc Cain is an accessible employer. If you require an accommodation throughout the recruitment process (including alternate formats of materials or accessible meeting rooms), please let us know and we will work with you to meet your needs. Your privacy is important to us.
By submitting personal data or information to us, you agree this will be handled in accordance with the Global Privacy Policy Job Family: Quality & Food Safety Division: NA Operations Department: Burley Quality Night Location(s) : US - United States of America : Idaho : Burley Company: Mc Cain Foods USA, Inc.
daily task in evaluating ingredients and backs food-safety and quality characteristics in finished products. Location: Topeka, KS Work Arrangements: onsite, 100% In this role you will: Partner with Quality Manager in developing and delivering on the site's Quality Pillar Master Plan Lead personnel responsible for product formulations, supplier compliance, quality systems software, and lab equipment maintenance and calibrations Drive accountability in team performance based on safety, quality, reliability, cost and sanitation standards Be the lead technical resource for quality teams across the site and support skill building through Smucker Quality Management Systems (SQMS) and High-Performance
Organization (HPO) design principles Support the technical services group by communicating ingredient substitutions, process modifications and in-plant test observations and evaluations Address quality concerns and lead root cause analysis to drive towards a zero-loss and continuous improvement culture Maintain key quality records in compliance with regulator 3rd party agencies Review documentation of process critical control points to ensure that legal standards are being met and that substandard product is contained Maintain open communication with the production team to ensure integrity of raw materials and finished product.
Conduct applicable process/system audits (on-line and in
reports) to ensure that the individual unit operations are in conformance with the site quality procedures Investigate and report customer and vendor complaints Manage hold inventories and their reconciliation among various inventory systems Participate in finished product holds and sample collection Recommend and implement quality and laboratory training topics to improve technicians skills and/or manufacturing processes The Right Place for You We are bold, kind, strive to do the right thing, we play to win, and we believe in a strong community that thrives together.
Our culture is rooted in our Basic Beliefs , and we believe in supporting every employee by meeting their physical, emotional, and financial needs.
What we are looking for: Minimum Requirements: Bachelor's degree in Science, Engineering or a related field3+ years of manufacturing operational experience Experience managing teams in a high-performance work environment Understand basic concepts of chemistry and microbiology Ability to effectively trouble-shoot and make proactive decisions Ability to work a flexible schedule (support site through key issues as needed)Additional skills and experiences that we think would make someone successful in this role: Experience in food processing and/or manufacturing Learn More About Working at Smucker Our Total Rewards Benefits Program Our Thriving Together Philosophy Supporting All Impacted by Our Business Our Continued Progress on Inclusion, Diversity and Equity Follow us on Linked In #LI-KK1#INDSA
enterprise located in the beautiful blue ridge mountains of Western North Carolina providing vocational training and employment opportunities to adults with disabilities and disadvantages in Haywood County, NC. HVO supports our mission through the production of medical drapes and other medical devices for domestic and international surgical needs.
HVO has more than 40 years of experience in manufacturing of disposable healthcare products and has created partnerships with some of the key players in the international healthcare industry. We would love to have you come join our team and help us continue to provide life changing services for individuals with disabilities and disadvantages.
JOB TITLE: Quality Assurance Inspector I (Part-time) EMPLOYEE STATUS: Non-exempt, hourly PURPOSE: To assist the Quality Assurance Department in the daily operations of assuring quality products through inspections and testing AREA OF PROGRAM RESPONSIBILITY: Quality Assurance ESSENTIAL DUTIES: 1) Performs necessary inspections and testing as needed and required to prevent non-conformances and assure quality products in the Medical and Custom Pak areas.
2) Maintain a working knowledge of all current product contracts, including specifications, tolerances, and procedures 3) Work with programs giving feedback on how clients perform on individual work tasks and behaviors, as requested 4) Assist
Quality Assurance Department with special testing or projects 5) Assist in the implementation of safe professional practices throughout the facility 6) Advise immediate supervisor of any problems that may arise in carrying out above responsibilities and assist with correcting that problem if necessary 7) Follow up on training of new employees/clients and assist as needed 8) Work with production staff to correct non-conformances as needed 9) Serve as a role model to demonstrate good work habits and behaviors 10) Work with production staff to answer Quality Corrective Action Reports as needed GENERAL DUTIES: 1) Comply with HVO safety rules and regulations 2) Receive incoming material as needed MINIMAL REQUIREMENTS/PERFORMANCE STANDARDS: 1) One year of experience in Quality Assurance or related production experience 2) Ability to learn and perform Quality Assurance policy and procedures as directed by HVO, FDA compliance standards, and ISO PHYSICAL REQUIREMENTS: Able to lift up to 40 pounds occasionally EDUCATION REQUIREMENTS: High school diploma/GED or an acceptable amount of applicable work experience Hours: Saturday and Sunday 6:00 am - 6:30 pm Rate: $13.90 per hour Job Posted by Applicant Pro
that values hard work, integrity and ethics. Professional Plastics is currently offering great career opportunities. We are interested in hiring motivated professionals who share our core values and desire to be part of a dynamic team. Professional Plastics is an equal opportunity employer and offers competitive pay and benefits.
Benefits Package: NEW Daily Pay - Provides early access to earned wages Medical Dental Vision Flexible Spending Account 401K Plan Basic Life and AD&D Voluntary Life Insurance Long Term Disability Employee Assistance Program Vacation Sick Leave Paid Holidays Position Summary: The Quality Control Inspector is responsible for conducting both quality assurance, quality
control and inspection activities. Assists in the development, improvement and implementation of current and new processes and procedures. Essential Duties and Responsibilities: Include the following, as well as other duties may be assigned.
Organize, prepare and perform internal audits for the branch per ISO 9001/AS9100 requirements Calibration Program – Equipment calibration, periodic verification. Corrective Actions – Assign, investigate and respond to opportunities for improvement. Certification of Conformance – Complete and submit supporting documentation as required. Equipment Maintenance – Scheduling and recording equipment maintenance. All Inspection activities – First Article,
In-Process and Final. RMAs, Scrap and Internal Rejects – Analyze all products and processes in order to identify root causes and problem resolution.
Implement and manage all calibration activities through formal programs. Documentation – Complete both internal and customer related documentation as required. Other duties and assignments as required. Experience: Experience in both quality assurance and quality control activities. Ability to read and interpret prints drawings and customer contractual requirements. Manufacturing and Inspection background experience preferred. Equal Opportunity Employer : Disability/Veteran Job Type : Full-time
will serve as the QCM overseeing the implementation and adherence to the Quality Control Plan, as well as periodic updates and maintenance of the Plan. Responsibilities ESSENTIAL DUTIES & RESPONSIBILITIESThe Essential Duties and Responsibilities are intended to present a descriptive list of the range of duties performed for this position and are not intended to reflect all duties performed within the job.
Other duties may be assigned. The Quality Control Manager (QCM) will describe all methods, procedures and documentation needed to fulfill the quality and safety of the contract. The QC manager will identify potential risk areas and will be responsible for the implementation, documentation,
and execution of the quality control on the project. The ideal candidate will ensure projects comply with applicable plans, standards, and specifications.
This role includes direct oversight and review of the entire documentation and physical inspection of the workflow process to ensure quality is maintained. Qualifications QUALIFICATIONS - EXPERIENCE, EDUCATION AND CERTIFICATIONTo perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required (Minimum) Qualifications Five years' experience as a quality control manager on industrial or commercial projects.
Federal project experience preferred. Experience on projects exceeding $500,000 (specifically HVAC and electrically heavy projects) Experience working with the Corps of Engineers (USACE) Current USACE or NAVFAC Construction Quality Management for Contractors (CQM) certification OSHA 30 Certification (can be obtained after employment) Current favorable National Agency Check with Inquiry (NACI), in accordance with AR 380-67Knowledge, Skills, Abilities, and Other Characteristics Ability to effectively communicate in English, both orally and in writing.
Ability to use a computer, Word, Excel, E-mail, etc. Ability to complete accurate daily Quality Control Reports, and lead preparatory, initial and follow-up phase meetings and inspections. Additional specialized training or education may be required based upon tasks or hazards associated with specific Delivery Orders as required by the Government. Valid Driver's License U. S. Citizenship (required for access to secure areas of Military Base) Experience working with a team to develop means and methods to complete construction tasks in a safe and efficient manner by identifying proper PPE and equipment.
PHYSICAL REQUIREMENTSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must maintain a constant state of mental alertness at all times. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential and marginal functions require maintaining physical condition necessary for bending, stooping, sitting, walking or standing for prolonged periods of time. Additionally, the ability to climb up and down ladders, walk on uneven, shifting surfaces, dirt, mud and gravel & up and down hills as well as occasional work in confined spaces.
The ability to pass a DOT physical and respirator fit testing may be required. DOT COVERED/SAFETY-SENSITIVE ROLE REQUIREMENTS This position is not subject to federal requirements regarding Department of Transportation " safety-sensitive" functions. WORK ENVIRONMENTWork Environment characteristics described here are representative of those that must be borne by an employee to successfully perform the essential functions of this job.
Job is performed both on active construction sites with exposure to all types of weather heat, cold, rain, snow, exposure to dust, dirt and noise, as well as in an office setting with exposure to computer screens and requires extensive use of a computer, keyboard, mouse and multi-line telephone system. Occasional travel may be required. Occasional " off-shift" evening/weekend/holiday work may be required. SUPERVISORY RESPONSIBILITIES Depending upon workload supervision of additional quality control employees and or subcontracted QC employees may be required. ADDITIONAL QUALIFYING FACTORS As a condition of employment, may be required to pass a pre-employment drug screening, as well as periodic random drug screenings, have acceptable reference and background check results to obtain access to secure areas of a military base.
Must have reliable transportation to/from work. Shareholder Preference. BSNC gives hiring, promotion, training and retention preference to BSNC shareholders, shareholder descendants and shareholder spouses who meet the minimum qualifications for the job. Bering Straits Native Corporation is an equal opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender, or gender-identity, age, marital status, interactionual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law.
Equal Opportunity Employer/Veterans/Disabled We participate in the E-Verify Employment Verification Program. We are a drug free workplace.
superior products and services. About Nooter/Eriksen: Nooter/Eriksen is an employee-owned company with headquarters in Fenton, MO and Milan, Italy. We specialize in HRSG (Heat Recovery Steam Generator) design, fabrication, equipment, and solutions for clients in the power industry, worldwide.
We offer a flexible work schedule with the option of working half-days on Fridays! We provide a full benefits package. Our 401(K) provides an employer match and an annual non-elective contribution. We provide medical with an employer contribution toward the HSA. Dental and Short-Term disability is 100% covered by the company. We also offer vision and fitness reimbursement. We pride ourselves on our
collaborative environment where employees are empowered to advance their career, explore career paths, and grow personally and professionally. DAY IN THE LIFE: The Manager of Quality Control reports directly to the Director of Supply Management and will analyze quality systems to ensure that risk to Nooter/Eriksen is mitigated within market economical constraints, interpret third-party quality backssments of fabrication, installation and operational quality issues, and supervise the Quality Department personnel, including quality and welding engineers and assistants.
As the Manager of Quality Control you will lead the department by communicating company and department goals, setting clear
expectations and actively coaching/developing staff; ensure that the Source Inspection process effectively reduces risk and minimizes cost due to fabrication errors, promote resolution of Quality issues with Supplier, and monitor all quality issues to ensure systematic problems are addressed; supervise the execution of Nooter/Eriksen's Quality Plan and ensure that required certifications are renewed from year to year for continued operations; develop new Quality requirements to meet company goals and develop customer relationships both at the project level and management level, proactively work with department heads to create a high-performance team, and engage with industry organizations that provide support to our quality efforts and provide an avenue for input into quality requirement changes; and travel 10-15% by car or plane.
KEY QUALIFICATIONS. We want the person selected for this role to be successful! The following qualifications are essential to be effective in this role: Four-year degree in engineering is strongly preferred. In lieu of an engineering degree, a four-year degree in a technical field with relevant work experience may be considered. Seeking at least eight (8) years of experience in quality, ASME Section I or VIII, heavy industry, manufacturing, construction, welding, non-destructive testing, and/or other similar fields.
At least three (3) years of experience leading and managing direct reports. Ability to read, write, problem solve, make quick decisions, interpret data and analyze results; effective written and verbal communication is essential. If you are interested in this position, please simply click the Apply button to get started! Our application is quick and should take you less than 5 minutes to fill out. Your information will be then sent directly to the Recruiter. Nooter/Eriksen is committed to creating and maintaining an environment in which all employees feel valued, included, safe, and empowered to do their best work.
We are proud to be an equal opportunity workplace and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, interactionual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. Pre-employment drug screen and background check required. Job Posted by Applicant Pro
we live our values, always, while setting the highest standards for performance. Here, you will make a difference every day. You will be part of a dynamic, collaborative, and competitive team. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire.
Make history with us. What role will you play? How will you make history with Campbell's? Apply today! Job Title: QA Technician AM Shift 4AM - 4PM Wage: $22.50 HOURS: (Starting times and hours may vary depending on coverage due to report-offs and the production schedule especially during holidays. )JOB SUMMARY/ JOB DUTIES: The Quality Assurance (QA) Technician is responsible for performing a variety
of routine laboratory operations in a quality assurance setting. Duties usually consist of making measurements, performing several routine quantitative and qualitative biological or chemical analytical tests according to standard procedures.
Monitors the production process and product by sensory, weight control, and analytical methods to maintain product consistency and comply with established specifications including color, moisture, p H, weight, size, etc. Evaluates all finished product in regard to moisture, ingredient content, breakage, color, package fill, raw and finished weights, seal integrity, code date legibility, and overall product quality. Accurately performs and documents
all testing. Testing may include: Inspection and testing of incoming raw materials, in process products, finished goods, and products produced by outside suppliers.
Utilizes testing equipment for validation and/ or calibration. Communicates all out-of-compliance situations and product standards to production employees and Production/QA Supervisors. Practices and adheres to safety and hygiene guidelines for safe house keeping and personal protection. Keeps all work areas clean, stores laboratory supplies in designated areas, keeps benches and aisles clear. Strictly adheres to safety procedures when handling chemicals for testing. Follows instructions for safe lifting.
Executes the Food Safety Plan and Food Quality Plan included in the SQF Program at the front line level. Monitors the Food Safety Plan and Food Quality Plan effectiveness and conformance with SQF system requirements Identifies, investigates and/or determines whether out-of-compliance finished product should be placed on hold. Coordinates disposition and/or rework with leadership approval. Monitors raw materials storage area locations and complete shift tailings. Notifies appropriate personnel with any abnormal findings. Monitors metal detection validation & verification. Audits allergen maintenance repair sheets and operator forms.
Conducts pre-op inspections of processing, packaging and mixing equipment after product changeovers and/or prior to weekly production start-up as a cross-functional team. Performs plant sanitation verifications to ensure allergen free and equipment is clean. If applicable may participate in Kleanz or respective program. Mandatory overtime is required. May perform other duties as required. EDUCATION/EXPERIENCE: High School Diploma or GED and/or 1-year production experience in a manufacturing environment required. PHYSICAL REQUIREMENTS: Sitting: Occasionally Standing: Continuously Walking: Continuously Using hands: Continuously Climbing: Occasionally Stooping, Kneeling: Occasionally Talking, Hearing: Continuously Tasting, Smelling: Frequently Two-Handed Carry: Frequently Stooping/Kneeling: Occasionally Climbing: Occasionally One-Handed Carry: Frequently Where applicable, ability to climb into trailer & walk on uneven surfaces in order to gather samples: Occasionally Weight: Up to 10 lbs.
Frequently Up to 25 lbs. Frequently Up to 50 lbs. Occasionally Up to 100 lbs. Seldom/Never More than 100 lbs. Seldom/Never WORK ENVIRONMENT: Subject to indoor facility and outdoor weather conditions, dust, noise, heat/cold.
Lighting: Good Temperature: Good Ventilation: Good Vibration: Fair Noise: Fair Compensation and Benefits: The starting rate for this full-time, hourly position is $22.50. Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package.
The Company is committed to providing equal opportunity for employees and applicants in all aspects of the employment relationship, without regard to race, color, interaction, interactionual orientation, gender identity, national origin, citizenship, marital status, veteran status, disability, age, religion, or any other classification protected by law. In that regard, U. S. applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. PDN-9ae1d5d8-00f5-44b6-9388-b144ca5681b2
The Construction Quality Control Manager (QCM) has overall responsibility for reporting directly to the Project Manager and Corporate Management for the verification that we meet all quality standards on our projects. The Quality Control Manager (project level) plans, coordinates, and oversees implementation of Construction quality control and quality assurance programs at the project level.
This position also creates reviews and amends Project Quality Plans to keep them current and to ensure compliance in all respects with the contract, established standards, methods, and specifications. Responsibilities ESSENTIAL FUNCTIONS: Create and manage the Quality Control Plan for success on assigned
construction projects Read and understand complex contract specifications, documents, and architectural/engineering/mechanical and electrical drawings Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables Define problems, collect data, establish facts, and draw valid conclusions Review and approve submittals, process, and understand RFI's Create a Daily Activity Report to be a detailed, thorough, and complete historical record of the day's daily activities.
Work with others in a team environment to ensure contract requirements, project goals and objectives are met Communicate and reason with client's
quality assurance personnel and technical experts, and field quality assurance, technical authorities, and construction supervisory representatives Make presentations, host meetings, and engage in problem solving by bringing together technical experts, authorities having jurisdiction, assigning action items, documenting minutes and follow through to closure Proficiency in QCS/RMS software applications, Word, Excel, and Outlook Prepare graphs, charts of data, proposals, reports, and manuals Implement the three phases of quality control Read survey shots (grade and elevation) Mentor Quality Control Specialists Other duties as assigned Qualifications PHYSICAL DEMANDS: An individual will be required to perform climbing, balancing, stooping, kneeling, standing, walking, pushing, pulling, lifting, finger, grasp, feel, talk, hear, and repeat motions.
Light Work: Exerting up to 40 pounds of force occasionally, and /or up to 15 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects is required. The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; viewing a computer terminal; reading; visual inspection involving small defects, small parts and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
We are a Federal Contractor and comply with the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA). We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, interaction, interactionual orientation, gender identity or national origin, disability, veteran status, and other protected characteristics. The EEO is the Law and the poster is available http: //www1. eeoc. gov/employers/upload/eeoc_self_print_poster.
pdf. For questions on the job posting contact (253) 344-xyz X If you need assistance or special accommodations during the application process, please contact the appropriate Human Resources Department at xyz X@. VEVRAA Federal Contractor We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state The EEO is the Law poster is available here. PDN-9ae1bdc1-57b0-4b34-b555-95c8e5b79520
Ensures daily operational staff follow written policies, procedures, customer requirements, EPA methods, and certification standards. This responsibility also includes review and approval of data generated in the laboratory and laboratory notebooks. Write, review and approve quality policies and procedures including SOPs, Work Instructions, Laboratory Analysis forms (Lab batch records), Quality Assurance Manual.
Train employees on new or changed procedures and maintain proper training records Set up new certification programs to meet individual state requirements Ensure certification requirements are being met; maintain proper records Lead internal and external audits Ensure audit responses
are completed in a timely manner serve as the primary author on all audit responses Manage laboratory investigations for any Out of Specification (OOS) results, customer complaints, provide written investigation reports that include resolution and corrective actions Stays up to date on EPA's PFAS methods (Changing LOQ requirements for the methods) Ability to wear personal protective equipment Performs other related duties as assigned Heritage believes that each employee makes a significant contribution to our success.
That contribution should not be limited by the assigned responsibilities. Therefore, this position description is designed to outline primary duties, qualifications and
job scope, but not limit the incumbent nor the company to just the work identified.
It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of our endeavors. Education/Experience: Bachelors of Science in Chemistry, Biology, Engineering. Minimum of 5 years in an environmental laboratory setting. Minimum of two years in an environmental quality assurance role is required. Experience in a GMP environment required with PFAS analysis a plus. Experience may substitute for education requirements. Knowledge and Abilities: Requires strong organizational, problem solving, oral and written communications, and writing skills.
Knowledge of Quality by Design is a plus. Strong analytical, critical, and creative thinker. Collaborative and team-oriented. Regular and predictable attendance is an essential function of this job. About The Heritage Group The Heritage Group (THG) is a privately held portfolio of companies focused on creating long-term value by building world-class businesses. Under four generations of family ownership, we employ thousands of people around the world, with operations across North America, Europe, and China, in the core industries of Environmental and Remediation, Specialty Chemicals and Fuel Products, and Construction and Materials.
Driven by innovation and research, our in-house R&D team, Heritage Research Group, specializes in helping our diverse set of companies evolve and adapt to a changing marketplace by providing cutting-edge solutions and exploring new opportunities in its state-of-the-art facility. And while acquisitions, partnerships, internal expansion, and startups may be our cornerstone, we're a family company at heart-aiming to build long-term relationships with our customers, vendors, and partners so that we can turn big challenges into even bigger opportunities to make a difference in the world.
The Heritage Group welcomes the diverse backgrounds, experiences, and perspectives of all to work together to accomplish our goals
business unit and be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.
Responsibilities Quality Engineer Responsibilities: Quality engineering support for manufacturing and project management Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans Act as the quality interface for a production team in responding to customer complaints using failure analysis, development
of corrective and preventative actions and trend analysis Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions Coach and mentor Quality Engineers Support validation activity of processes, equipment, and metrology Support and comply with the company Quality System, ISO, and medical device requirements Qualifications Quality Engineer Requirements: Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science 6 years of experience in engineering in a machining or manufacturing setting Knowledge of quality systems, regulatory requirements, and industry standards Advanced knowledge of blueprint
reading and GD&T Ability to operate a variety of inspection equipment Statistical expertise with DOE and Capability Studies Design software- Minitab Quality Engineer Preferred Requirements Continuing Education; including participation in local chapters, associations, and/or organizations Physical & Environmental Demands: Cretex Medical uses cutting oils, solvents, and other chemicals in the manufacturing process.
Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels. What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees.
Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: " The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right. " " I would tell potential interns that Cretex is a great company to work for.
It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it. " " I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives. " We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Company Benefits Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options.
Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay. Cretex Medical also offers company-specific benefits, such as: Employee Appreciation events Volunteer Opportunities Training and Development opportunities Tuition Reimbursement New state-of-the-art facility in Brooklyn Park! Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, interaction, interactionual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.
Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www. dhs. gov/E-Verify.
of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference
in our success. The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Quality Assurance related R&D activities from research through product launch.
This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with Quality Engineers to ensure effective verification of design specifications and requirements. Monitors and ensures compliance with company policies and procedures (e. pliance with FDA, BSI, CSA, etc. ). Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation. Active participant in the development of product requirement, product system hazard analysis and design reviews.
Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support and expertise and analytical problem solving for product development and manufacturing Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams What Success Looks Like in This Role: Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Knowledge of product development processes Represents Quality organization on cross-functional product development Core Team(s)Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience Basic Qualifications: Bachelor's degree in Engineering (or relevant STEM field) and minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control Experience with software and hardware development within a regulated environment is preferred.
Thorough understanding of the risk management and quality by design is preferred Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred)Applicants must be authorized to work for ANY employer in the US.
We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions.
If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference in our success. The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Quality Assurance related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts.
Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with Quality Engineers to ensure effective verification of design specifications and requirements.
Monitors and ensures compliance with company policies and procedures (e. pliance with FDA, BSI, CSA, etc. ). Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation. Active participant in the development of product requirement, product system hazard analysis and design reviews. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support and expertise and analytical problem solving for product development and manufacturing Ensure product technical files and Design History Files are complete and auditable.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams What Success Looks Like in This Role: Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Knowledge of product development processes Represents Quality organization on cross-functional product development Core Team(s)Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience Basic Qualifications: Bachelor's degree in Engineering (or relevant STEM field) and minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control Experience with software and hardware development within a regulated environment is preferred.
Thorough understanding of the risk management and quality by design is preferred Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred)Applicants must be authorized to work for ANY employer in the US.
We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.
And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job PDN-9ae1d1d4-be9b-4576-9da5-227b73a266e9
of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference
in our success. We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.
It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The
Senior Software Quality Engineer is a key member of the New Products Development Team and is responsible for QA-related R&D activities from research through product launch.
This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the primary quality representative for design control projects - new product development as well as sustaining efforts. Responsible for review and/or approval of design history file documentation in support of design controls. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with other Quality Engineers to ensure effective verification of design specifications and requirements. Monitors and ensures compliance with company policies and international standards. Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work closely with Product Management to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.
What Success Looks Like in This Role: Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Applies intermediate understanding of regulatory requirements (c GMP, FDA, ISO, etc. ) to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods Able to pull reports (queries), interpret trends and make recommendations for improvement to existing processes and tools Uses comprehensive expertise to help improve and streamline the software quality or development process Represents Quality organization on cross-functional product development Core Team(s) Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers Considered expert in critical areas of the system and influences project test solutions Can apply understanding of the inter-workings of the application code under test Participates in design reviews Applies software engineering knowledge to tasking (e.
g. code and detailed design reviews, low-level white box testing, etc. ) Applies knowledge and skills to a wide range of standard and non-standard situations Basic Qualifications: Bachelor's degree in Engineering (or relevant field) and minimum 5 years' experience with emphasis on Software Quality Assurance and Design Control Thorough understanding of the risk management and quality by design Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Experience in software development and experience within a regulated environment is preferred applicants must be authorized to work for ANY employer in the US.
We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be phenomenal, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.
At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference in our success.
We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
Become a maker of possible with us. The Senior Software Quality Engineer is a key member of the New Products Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the primary quality representative for design control projects - new product development as well as sustaining efforts. Responsible for review and/or approval of design history file documentation in support of design controls.
Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with other Quality Engineers to ensure effective verification of design specifications and requirements.
Monitors and ensures compliance with company policies and international standards. Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements. Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work closely with Product Management to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete and auditable.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams. What Success Looks Like in This Role: Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Applies intermediate understanding of regulatory requirements (c GMP, FDA, ISO, etc. ) to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods Able to pull reports (queries), interpret trends and make recommendations for improvement to existing processes and tools Uses comprehensive expertise to help improve and streamline the software quality or development process Represents Quality organization on cross-functional product development Core Team(s) Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers Considered expert in critical areas of the system and influences project test solutions Can apply understanding of the inter-workings of the application code under test Participates in design reviews Applies software engineering knowledge to tasking (e.
g. code and detailed design reviews, low-level white box testing, etc. ) Applies knowledge and skills to a wide range of standard and non-standard situations Basic Qualifications: Bachelor's degree in Engineering (or relevant field) and minimum 5 years' experience with emphasis on Software Quality Assurance and Design Control Thorough understanding of the risk management and quality by design Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Experience in software development and experience within a regulated environment is preferred applicants must be authorized to work for ANY employer in the US.
We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be phenomenal, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job PDN-9ae1d1d4-f53d-4c3c-acd6-ec24caa1ed10
