improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects
and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups
and Suppliers to produce 510K submissions, letters to file, etc.
as required. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19.
This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 2 years of experience in the Quality or Engineering. Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.
g. 21 CFR 820, ISO13485). Position requires up to 15% travel. PREFERRED JOB REQUIREMENTS At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
and maintain product specifications and design control files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine
trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs.
Lead supplier qualifications. Provide Quality textiles expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc. as required.
Coordinate product testing with internal and external laboratories as required.
Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 2 years of experience in the Quality or Engineering.
Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary. Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.
g. 21 CFR 820, ISO13485) PREFERRED JOB REQUIREMENTS At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
and industry-leading transparency. With control of the entire supply chain, a state-of-the-art extraction campus near North Carolina's Research Triangle, proprietary refinement and conversion methods backed by a growing IP portfolio, and a team of Ph D chemists and seasoned business leaders, OBX is positioned to be the trusted partner for global brands seeking to enter the marketplace.
THE POSITION We are seeking an experienced Quality Assurance Label Associate/ Specialist (dependent upon experience) who will be responsible for managing label control, reconciliation, and issuance programs as part of our expanding Quality Management System (" QMS" ) which includes: industry,
regulatory, and c GMP manufacturing compliance and certification programs; in-house and third party product quality testing throughout the manufacturing process; and comprehensive SOP's and employee compliance training.
The Quality Assurance Label Associate/ Specialist (dependent upon experience) must bring a high level of energy and possess the leadership and flexibility to adapt to the evolving and infant regulatory landscape of the industry. RESPONSIBILITIES Conducts inspections of incoming retail labels Implementation of a label repository and the authority on label version control Maintains physical inventory and updates documentation of the usage of retail labels Ensures the label
storage locations are maintained in a secure fashion Responsible for label issuance to Finished Goods Manufacturing and Label Reconciliation during and post production Conducts obsolete label and other customer branded material destruction and maintains records accordingly Performs verification that the components listed in the Bill of Materials are correct and compatible with each other and the manufacturing equipment Gathers routine samples from manufacturing areas, performs the required analysis, and records and reports data in a timely manner Coordinate with department managers to develop, write, review and approve SOPs for the entire operation, from through finished product shipping and ensure SOPs are compliant across multiple regulatory frameworks.
Ensure finished products meet labeling standards for hemp including compliance with FDA regulations for foods and dietary supplements, ingredients, limitations on health claims, disclaimers and warnings. General oversight of facility recordkeeping, following Good Documentation Practices Other tasks as necessary to meet business needs. EXPERIENCE HS or equivalent required BS or equivalent in the physical sciences preferred Suggest " At least one year minimum required experience in the food, dietary supplement or medical industry Experience in the cannabis industry preferred but not required.
Strong knowledge of c GMP regulations and auditing techniques. Solid understanding of Quality Control and Quality Assurance c GMP requirements in FDA regulated environments preferred. High level of interpersonal skills, strong leadership abilities, organizational and time management skills. Excellent communicator. Ability to work independently and meet deadlines. OTHER DETAILS This is a full-time position based out of Roxboro, NC. Compensation commensurate with experience. Background and reference checks required.
PHYSICAL DEMANDS AND WORKING ENVIRONMENT: Must be able to lift, carry and balance up to 50 pounds While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and completing repetitive motions. Ability to walk and stand for long periods of time (4-6 hours) with frequent kneeling and bending. Working in limited climate-controlled facilities and may experience extreme heat or cold Work with heavy fumes, plants, airborne particles and chemicals Must be comfortable working with and around heavy machinery May experience moderately high noise levels EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Open Book Extracts is proud to be an equal opportunity employer.
We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
at the time of hire and is based on experience. Responsibilities? Strong communication skills. Strong decision skills. Project Management/leadership. ISO 9001 Quality Management Systems Course. API Spec Q1 Practitioner course or equivalent. Assist process owners in developing new processes.
provide guidance in order to motivate and ensure personnel are carrying out responsibilities within the Quality Management System (QMS) in an effective and efficient way. establish, implement, and maintain Quality Management System (QMS). report to top management on the QMS performance and where improvements are needed. establish trends to determine the direction of the QMS's performance. ensure that
all personnel are aware of customer requirements. deliver management system training. control all aspects of quality of production efforts. maintain calibration of equipment.
coordinate with certifying entities. represent management during certification and surveillance audits. ensure the compliance of the QMS as per the ISO 9001 standard and API Spec Q1. prepare audit schedules, audit reports, and identify nonconformities. conduct internal audits. root cause analysis. communicate to top management on quality issues and non-conformities and audit reports. measure and monitor process performance; opportunity and risk identification as well as risk backssment and management. resource management.
measure equipment management. coordinate and communicate with customers.
Additionally: -Develop and implement quality control processes and procedures to ensure compliance with industry standards and regulations. - Conduct regular quality audits to identify areas for improvement and implement corrective actions. - Oversee quality inspection activities to ensure products meet specified quality standards. - Collaborate with cross-functional teams to develop and implement quality management systems. - Manage projects related to quality control, including coordinating resources, setting timelines, and monitoring progress. - Stay up-to-date with industry trends and advancements in quality control practices.
- Train and educate employees on quality systems, CGMP, and FDA regulations. Experience: - Proven experience in quality control management, preferably in a manufacturing or production environment. - Strong knowledge of QA/QC principles, HACCP, and quality systems. - Experience conducting quality audits and implementing corrective actions. - Proficient in project management methodologies and tools. - Excellent analytical skills with the ability to interpret data and make informed decisions. - Strong attention to detail and ability to identify areas for improvement.
- Excellent communication skills, both written and verbal. Note: This job description is intended to provide a general overview of the position. Other duties may be assigned as needed. Education required Bachelor's of Engineering or equivalent with emphasis of Mechanical Engineering; additional education preferred but not required, Bachelor's of Business Administration with emphasis on Quality Management. ISO 9001 Quality Management Systems Course API Spec Q1 Practitioner course Position available immediately upon hire. Competitive wages and benefits. Benefits include health care after 60 days of employment.
We cover 85% of the employee premium. May be required to travel to Oilwell sites within Odessa, Texas, customer area as needed. At times, travel may be daily, often times will be infrequent. Must be able to pass a pre-employment drug and alcohol test and will be subject to random testing. Work location: In Person
schematics, drawings, and wiring plans to test circuit boards and assembled product to ensure only top quality products are shipped to our customers. They use Excel for data entry of testing results, are comfortable navigating in an ERP system, and have great communication skills to provide information to internal groups including sales and product development.
We need talented, dedicated people who have these skills and experiences for success: High School diploma or GED 3 years related experience in circuit board testing and assembled product testing Strong organizational and interpersonal skills to get the job done Computer experience which includes MS Office and ERP System experience
IPC 610 and J-STD-001 certifications or the ability to successfully complete in house training to gain those certifications At Com Sonics Manufacturing Solutions, our team of talented coworkers make the impossible possible!
The products we manufacture and repair support a wide range of industries and make a positive difference in the lives of others. We offer a friendly, temperature controlled work environment where your results are recognized and rewarded. Plus we offer good pay, benefits, and the opportunity to join a successful employee owned company! Does this sound like an environment that brings out the best in you? If so, check us out and apply for the opening. We can't wait to
hear from you! Com Sonics is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, veteran status or other protected status. Job Posted by Applicant Pro
as directed by the quality manager. Provide leadership and direction to quality assurance staff to include monitoring staffing levels, training, scheduling, performance and more. Conduct routine quality management system audits to assure conformance with contractual and company requirements.
Perform audits, which includes audit preparation, execution, report development, non-conformance tracking, and follow-up/closure activities that meet schedule demands. Assign and lead departmental tasking to include developing project planning estimates, establish, and verify quality control principles are followed, and develop project quality metrics to assure conformance with contractual requirements.
Perform special audits or inspections on request, targeting areas of particular interest. Issue, verify, monitor, and validate effectiveness of corrective and prepare preventive action (CA/PA) plans.
Routinely monitor and inspect equipment and facilities and audit processes to determine that conditions are in accordance with contract requirements. Perform quality control functions to include site inspections, configuration control walk downs, review of workmanship standards, facility and habitability reviews, and brief management on findings. Identify and exercise judgment in identifying attributes or situations which may lead to a future risk, noncompliance, or safety and environmental
impact to the contract. Other duties as assigned. REQUIRED: This position has been posted at multiple levels (must meet minimum level indicated).
Depending on the candidate's experience, requirements, and business needs, we reserve the right to consider candidates at any level for which this position has been advertised. This position requires US Citizenship or U. S. naturalization due to the sensitivity of customer related information. This position requires a Secret Clearance, or the ability to obtain one. Must have a bachelor's degree in business management, engineering, or computer science, or related field. Must have 10+ years of recent and related quality assurance work experience.
In lieu of degree: Candidates with 14+ years of related work experience will be considered. Knowledge of Aerospace Standard AS9100 or ISO9000. Ability to work in industrial/administration spaces, often in remote environments where hazards are present that requires specialized training (fall protection, energized equipment, forklift operation, etc. ). DESIRED: Knowledge of Department of Defense, Federal Acquisition Regulations, Aerospace Standards, Air Force, and Government Technical Orders. WORK LOCATION: This position offers a hybrid work schedule. This position may require some travel.
BACKGROUND INVESTIGATIONS REQUIRED: All Bastion employees must be able to pass a national agency check, some positions require a clearance and will require an extensive background verification/check process. DRUG AND ALCOHOL SCREENING REQUIRED: All Bastion employees must be able to pass pre-employment drug screen; some contracts require participation in periodic random drug and alcohol screening programs. STANDARD BASTION REQUIREMENTS: Must have experience with Microsoft Office Suite. All of Bastion's employees must be team players. Able to communicate effectively, verbally and in written form, with internal and external customers.
Able to follow company programs, processes, procedures, practices, requirements, goals, and objectives. Must have a strong work ethic and must be safety culture oriented. Must be organized with good time management skills. Generally, an office environment, but can involve inside or outside work depending on the task. Work may involve sitting or standing for extended periods (90% of time). May require lifting and carrying up to 25 lbs. (5% of time). Regular attendance in accordance with an established work schedule is critical.
Ability to work outside normal schedule and adjust schedule to meet peak periods and surge requirements. BASTION BENEFITS: Bastion offers a wide range of benefits for their full-time employees; medical, prescription, dental, vision, AD&D, disability benefits, life insurance, retirement 401k, vacation, sick pay, holidays, and flexible work schedules (when available). We also support career advancement through professional training and development. ABOUT BASTION: Bastion offers career opportunities with competitive benefits, exciting possibilities for advancement, and an exceptional work environment; the well-being of our employees is a priority, and our flexibility allows our employees a great work life balance.
Our culture is based on strong business ethics, integrity, and professionalism. Our team members are known for their initiative and high-quality work. When it comes to our employees, we value, respect, and help them grow in their careers. INCLUSION AND DIVERSITY: At Bastion, we are passionate about our people and our safety culture. We are committed to a journey toward being a more inclusive and diverse company, that philosophy fosters an environment of collaboration across cultures.
Individual thoughts, opinions, and perspectives bring value and help us develop solutions for challenging problems, they make us more inventive, and more resilient. All qualified applicants will receive consideration for employment without regard to race, color, interaction, interactionual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. Bastion participates in e-Verify. #Mid Senior Level #LI-Hybrid BT-23161 Job Posted by Applicant Pro
and validate solutions provided by the development team to ensure the data is accurate and consistent with the end user expectations. You will also be part of a broader team of business analysts focused on ensuring the accuracy of data across the Company's Data Management program.
Duties Perform data analysis, testing and validation Design and execute test cases to ensure the accuracy and completeness of data based on user and/or system requirements. Perform analysis of data from various data sources needed to meet business requirements. Maintain appropriate test documentation. Develop and maintain a deep understanding of the Company's data warehouse environment. Maintain a strong understanding
of business information data sources and business rules. Assist in gathering end user requirements for data, data quality and performance. Work with scrum masters, product owners and agile development teams to ensure solutions are delivered in a timely manner in accordance with business expectations.
Build strong relationships with business and IT partners. REQUIRED Bachelor's degree in Information Technology, Business or related discipline 3+ more years of related experience Significant experience writing and editing SQL queries , or with other relational database tools such as Apache Groovy Proven experience in capturing and documenting test plans, test cases and test results related
to system enhancements, maintenance and new functionality requests.
Excellent analytical and problem-solving skills. Preferred Experience working in data warehouse environment Experience with data validation tools such as i CEDQ Comfortable working in an agile development environment Notes: Core data warehouse team - working with the data, looking at the reqs, work with product owner and technical team, verifying that what is being delivered is what was requested, large volumes of data. Proficient in SQL - tables joins, calculations. Not hard core development, but needs to have it. Testing tool is ICQ, but would be a nice to have or pick it up. 3+ years of experience. PDN-9ac9aae3-1deb-4a0b-bd5f-c2a147cdbfaa
and with integrity. REQUIREMENTS/DUTIES : Must meet the following standards of service as evaluated by our internal and external members. I will provide accurate information. I will respond and follow through with all requests in the agreed upon time frame.
I will conduct myself in a friendly and professional manner. I will listen effectively and offer solutions appropriate to you individual needs. I will project a whatever it takes attitude. I will address you by name and thank you for your business. Follow up on accounts that are in default due to missing encumbered title. Process documentation for lien encumbrances in accordance with various state requirements. Maintain and update
all electronic title reports via VINtek and Dealer Track. Perform all title maintenance, including lien expiration, and maintain and update necessary documentation.
Research, analyze, and prepare documents pertaining to lease buyout vehicles and update/communicate with members throughout the process. Perform all clerical tasks related to each member account and file hard copies of titles. Work directly with recovery companies to secure the credit union's collateral; Secure vehicles after they are financed. Work with outside agencies to transfer titles from state to state and prepare the necessary transfer documentation. Release all paid-in-full auto loans and send to the proper owner.
Register vehicles under Carfax VIN watch as a collection effort to obtain liens.
Verify and make corrections to VIN errors when necessary. Verify all auto loans for lien releasing that are paid in full. Perform tracking of all electronic titles. File and track all paper titles. Remain current and knowledgeable of all aspects of local, state and federal regulations that affect the credit union. Remain active in the University Program of American Heritage Credit Union and complete the position's present curriculum as outlined in the Online University by completing the following - Credit Union annual required compliance training, the Online University required coursework within assigned timeline, and the supplemental courses listed in the Online University Curriculum within the prescribed timeline.
QUALIFICATIONS: One year to three years of similar or related experience. Experience in Microsoft Word and Excel. Working knowledge of Symitar, VINtek, Dealer Track, and Carfax. EDUCATION Requires education equivalent to a four-year high school diploma WORK HOURS Full time position, occasional overtime and alternating Saturday hours may be required Administrative building To be considered, correspondence should include a resume listing job history and salary expectations.
Please be advised that credit, criminal, employment, drug/alcohol testing and education background checks are conducted on potential candidates. All resumes will be reviewed, but only competitive candidates will be contacted for further conversation.
familiar with site processes, procedures, and policies as individual develops knowledge aligned with c GMPs and Health Authority regulations. The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews. Supports special projects as assigned. The role follows c GMP and routinely makes decisions using c GMP/process knowledge.
May work with customers to resolve problems and to satisfy quality and production needs. Follow site safety requirements. Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams. The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections. Qualifications: Bachelor's degree in science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the medical industry. Preferred Experience and Skills:
Previous experience supporting aseptic operations or sterile products, experience in Quality Assurance/Engineering role or Technical role.
Previous experience in food or medical environment in regulatory/inspection role. Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP, Midas, or Track wise. Additional: Beta Lactam screening required for this role. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Rajesh chitrada - xyz X PAY RANGE AND BENEFITS: Pay Range: Between $36.00 - $39.92 Per Hour Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & shop coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) Clearly Rated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : / Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-xyz X. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.
Innova Solutions (Hire Genics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U. S. C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy. PDN-9ac9aae5-922c-4b5f-af98-0f77eeaa6ea8
improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects
and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups
and Suppliers to produce 510K submissions, letters to file, etc.
as required. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19.
This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 2 years of experience in the Quality or Engineering. Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.
g. 21 CFR 820, ISO13485). Position requires up to 15% travel. PREFERRED JOB REQUIREMENTS At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
