Location: Maryland Heights, MO
Management System (QMS) from ISO9001:2015 to ISO13485:2016 at 3 locations, including one in Costa Rica. This is a critical project for us, as it will enable us to streamline our processes and ensure compliance with the latest industry standards. As the Quality Manager, you will play a key role in driving this initiative forward, and you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the medical device industry.
This position offers an excellent opportunity for an experienced candidate to advance their career and make a significant impact on the success of our organization. Duties and responsibilities Lead the organization
to establish and continuously improve the Quality Management System; including certification to the current ISO 9001:2015 Quality Management Systems Requirements across multiple sites.
Upgrade the organization to ISO 13485:2016 across multiple sites. Oversee effective deployment of human resources throughout the department. Serve as the ISO Management Representative for the EDC Management Team, including administration of periodic Management Reviews; review and maintenance of the Quality Policy, Quality Manual, QMS Plan and Quality Objectives; and response to external QMS related inquiries. Provide quality management support for all QMS processes, with specific oversight and implementation
responsibility for Nonconformities, Corrective Actions, Document Control, Internal Auditing, and QC Inspection of Image Bundles and Small Diameter Subassemblies.
Performs root cause analysis and works with Production Support to prevent manufacturing defects. Provide QMS Communication and Awareness training throughout the organization; providing daily direction and guidance as needed to ensure accurate and consistent application of QMS processes. Coordinate external audit activities and serve as primary contact for certification and surveillance audits, 3rd party and customer audits. Manage customer complaints, establish trending, implement corrective actions and respond appropriately to all investigation requests.
Reviews daily on-the-floor quality related issues with other applicable department management to determine need for corrective actions. Reviews incoming returned product from customers as either nonconforming product or returns for restock. Works directly with customers on review of nonconforming product to include issuance and management of corrective actions (8D's), as required, and visits to the customer facilities to report on actions taken to address quality concerns. Works with suppliers on incoming product quality issues to include issuance of supplier corrective actions, as necessary.
Works with R&D to ensure all product specifications are developed for new products and maintained throughout batching process and production for all products. Support needs of external customers as needed. Qualifications Minimum of bachelor's degree in relevant business or scientific discipline, or a bachelor's degree and a minimum of four years of related experience Prior leadership experience and maintaining an ISO 9001 certified or comparable QMS. Working knowledge of 6 Sigma and Lean Methodology Working knowledge of process validations Possess strong communication and interpersonal skills to address and resolve issues in a positive manner.
Excellent working knowledge of MS Office products, document control systems and quality management tools. Ability to work without being distracted by internal or external influences to effectively execute the above listed duties and responsibilities. Working conditions The job is performed at our facility at 14062 Riverport Dr. in a climate controlled non-smoking environment. It requires a person to work a standard day consistent with exempt employee expectations, where occasional extra effort may be needed to support the organization's needs.
The position may also require occasional overnight travel.
with other departments regarding Receiving and Quality Control requirements. Record, Disposition and Investigate NCRs and RMAs in a timely manner. Comply with applicable Quality Management System requirements; including Quality Policy, Quality Manual, QMS Procedures, Work Instructions, Forms, Recordkeeping, etc.
Support and fully participate in QMS related activities Participate in cross-training to improve ongoing efficiency and business continuity. Maintain clean and orderly work environment. Participate in end-of-year inventory process and assist in resolution of inventory discrepancies. Perform other tasks as deemed necessary by Supervisor. Qualifications High School diploma or equivalent
education Can effectively execute the above listed duties and responsibilities without limitations Follows written and verbal directions with limited oversight Effectively communicates, reads and writes in English language Able to multi-task with frequent interruptions in a fast-paced environment Can perform and cross-train associates in detail-oriented QC inspection techniques Able to interpret QC technical drawings and diagrams Able to carefully handle fragile items and inspect under microscopic magnification Willingness to work on interdepartmental assignments as required Working conditions The job is performed at our facilities in a climate controlled non-smoking environment.
It requires
a person to work day shift and overtime as peak workload may require.
Physical requirements The job requires standing and sitting for extended lengths of time and the ability to lift and manage packages and products weighing up to 30 lbs. Direct reports None.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiomedical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine.
The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team. Summary of Position Perform assigned laboratory testing and related
quality control activities in order to ensure compliance with applicable SOP's and c GMPs. Provide timely testing and notification of any aberrant occurrence to Management/Supervision that presents potential negative impact to manufactured or marketed product.
May supervise the work of others and coordinate instrumentation use and completion of laboratory testing. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Essential Functions Ensure a safe and quality working environment through training, awareness, and compliance to Safety/Quality guidelines and SOPs. Ensure the maintenance of their department, premises, and equipment.
Ensure that all necessary training is carried out to perform all the assigned tasks confidently and consistently.
Perform all work in compliance with site safety and radiation protection guidelines. Collaborate with other team members to ensure that quality tasks are performed in a timely manner. Must demonstrate flexibility in adjusting to changing priorities and schedules. Attend mandatory trainings as required by site regulatory requirements and management. Assist with investigations by providing testing results and communication of practice(s). Assist in the training and development of employees. Perform other general duties associated with the position as required by supervision.
Requirements Associate Degree in life science or a related field or completion of 4 college-level life science courses required. Bachelor’ Degree in life science or a related field preferred. 3 or more years of general quality / quality control / production experience in a c GMP facility required. Proficient in the use of several of the following laboratory instruments: Analytical Balance, p H meter, automatic pipettes, FTIR, UV-Vis, Voltammeter, Autotitrator, HPLC, GC, IC, ICP, Flame AA, TOC and Conductivity meter. Ability to work independently and with others to accomplish goals and priorities.
Flexibility and teamwork skills. High level of energy and regular, consistent attendance. Working Conditions: Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities also include the ability to lift 70 pounds, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation. Must be willing to wear a variety of personal protective equipment. Willingness to work in a team-based environment.
Close attention to detail required. May be required to sit or stand for long periods of time while performing duties. Must be able to work outside of regular work hours. Must possess good hand-eye coordination.
regulatory standards.
Quality Inspectors support manufacturing and servicing operations by performing incoming component and in-process product inspections using standard measurement equipment. They identify, segregate and document rejected material and participate in Material Review Boards to ensure the proper documentation and disposition.
They may also review other related Quality documentation such as device history or calibration records.
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
Management System (QMS) from ISO9001:2015 to ISO13485:2016 at 3 locations, including one in Costa Rica. This is a critical project for us, as it will enable us to streamline our processes and ensure compliance with the latest industry standards. As the Quality Manager, you will play a key role in driving this initiative forward, and you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the medical device industry.
This position offers an excellent opportunity for an experienced candidate to advance their career and make a significant impact on the success of our organization. Duties and responsibilities Lead the organization
to establish and continuously improve the Quality Management System; including certification to the current ISO 9001:2015 Quality Management Systems Requirements across multiple sites.
Upgrade the organization to ISO 13485:2016 across multiple sites. Oversee effective deployment of human resources throughout the department. Serve as the ISO Management Representative for the EDC Management Team, including administration of periodic Management Reviews; review and maintenance of the Quality Policy, Quality Manual, QMS Plan and Quality Objectives; and response to external QMS related inquiries. Provide quality management support for all QMS processes, with specific oversight and implementation
responsibility for Nonconformities, Corrective Actions, Document Control, Internal Auditing, and QC Inspection of Image Bundles and Small Diameter Subassemblies.
Performs root cause analysis and works with Production Support to prevent manufacturing defects. Provide QMS Communication and Awareness training throughout the organization; providing daily direction and guidance as needed to ensure accurate and consistent application of QMS processes. Coordinate external audit activities and serve as primary contact for certification and surveillance audits, 3rd party and customer audits. Manage customer complaints, establish trending, implement corrective actions and respond appropriately to all investigation requests.
Reviews daily on-the-floor quality related issues with other applicable department management to determine need for corrective actions. Reviews incoming returned product from customers as either nonconforming product or returns for restock. Works directly with customers on review of nonconforming product to include issuance and management of corrective actions (8D's), as required, and visits to the customer facilities to report on actions taken to address quality concerns. Works with suppliers on incoming product quality issues to include issuance of supplier corrective actions, as necessary.
Works with R&D to ensure all product specifications are developed for new products and maintained throughout batching process and production for all products. Support needs of external customers as needed. Qualifications Minimum of bachelor's degree in relevant business or scientific discipline, or a bachelor's degree and a minimum of four years of related experience Prior leadership experience and maintaining an ISO 9001 certified or comparable QMS. Working knowledge of 6 Sigma and Lean Methodology Working knowledge of process validations Possess strong communication and interpersonal skills to address and resolve issues in a positive manner.
Excellent working knowledge of MS Office products, document control systems and quality management tools. Ability to work without being distracted by internal or external influences to effectively execute the above listed duties and responsibilities. Working conditions The job is performed at our facility at 14062 Riverport Dr. in a climate controlled non-smoking environment. It requires a person to work a standard day consistent with exempt employee expectations, where occasional extra effort may be needed to support the organization's needs.
The position may also require occasional overnight travel.
REQUIREMENTS Three to five years' experience in quality assurance/manufacturing environment B. S. degree in an engineering discipline strongly preferred POSITION REQUIREMENTS AND PREFERRED KNOWLEDGE, SKILLS AND ABILITIES Proficient in use of statistical analysis tools.
Strong problem-solving and analytical skills. Experience leading a team through change. Excellent technical communication skills. Ability to interpret product specifications and drawings. Ability to interpret testing procedures and develop test reports based on findings. Ability to collect, analyze and interpret data. Ability to articulate issues clearly to both technical and non-technical team members. Ability to efficiently
organize and manage multiple priorities Ability and desire to grow in the position and accept more responsibility. Ability to take initiative in providing new ideas to improve process efficiencies.
Ability to maintain consistent attendance, arriving on time and prepared for all shifts, meetings, and appointments. ESSENTIAL RESPONSIBILITIES, EXPECTATIONS, AND BEHAVIORS include, but are not limited to, the following: Support of daily manufacturing goals by managing an in-process and final inspection process. Support implementation of strategic plans and implements QA objectives set by QA Coordinator. Supports and sustains a robust QA inspection process. Assists in management of Company's
general compliance with CPSC regulations, ASTM & other federal, state, & agency regulations regarding product safety and labeling requirements.
Audit Excelligence branded and non-Excelligence branded product for appropriate tracking labels; work with vendors to resolve non-compliance. Audit outbound customer shipments for quality; analyze customer complaints & reviews relevant to physical order shipments; partner with Operations and Customer Service to analyze and resolve quality concerns and customer complaints related to outbound customer packages. Assist Product Development team in evaluating new product samples from vendors; assist to resolve/address specific quality concerns.
Develop concise product specifications in conjunction with Product Development for new products. Coordinate on site vendor inspections by Children's Factory and third-party inspection providers Implement relevant procedures pertaining to the Quality Management Systems (QMS) by managing associated processes and procedures. Review quality data (internal and external) and drive feedback to QA team by establishing an effective improvement plan for defects prevention and achieving QDR (quality data review) goals. Participate and support quality related meetings (internal and external) as required Participate and support implementation of quality improvement initiatives Coordinate and support customer related inspection activities on/off-site as required Participate and support internal audits and external periodic QMS audits Maintain and update QA certifications/records.
Escalate any quality concerns or issues in a timely manner Keeps track of QA trends and regulations to ensure effectiveness and compliance Lead problem solving teams on and off the manufacturing floor Develop and execute Manufacturing Floor audits Manage internal and external testing activities In office attendance is an essential function of this position.
WORKING CONDITIONS The essential functions of this job require the employee to perform the following physical activities: Regular use of PC, laptop, copier, fax, and other general office equipment. Ability to access all areas of the facility to perform essentials functions of the position. Noise level for this environment is low to moderate. Children's Factory is proud to be an Equal Opportunity Employer Children's Factory is an Excelligence Company. Excelligence is an Equal Employment Opportunity (EEO) Employer. We are committed to providing equal employment opportunities to all employees, employment applicants and other covered persons without regard to unlawful considerations of race, color, religion or creed, gender, interaction, pregnancy, gender identity or expression, interactionual orientation, marital status, national origin or ancestry, ethnicity, citizenship status, genetic information, military or veteran status, age, physical or mental disability, or any other classification protected by applicable local, state, or federal laws.
your skills to grow with a great company? Then, this position is right for you! Quality Assurance Technician I - Batch Record Review Position: Full time Our offer: Medical/Dental/Vision Plan Insurance, Short and Long-Term Disability and Life Insurance after 60 days.
3% Safe Harbor contribution to your 401k. Up to a 4% Discretionary Match (like a profit-sharing contribution) to your 401k. Paid Time Off (PTO) Employees eligible first day of employment. 9 Company Paid Holidays (72 hours) each year. Uniforms Provided Foot Protection- annual allowance for all laboratory, maintenance and production employees. 24-hour access to our free, on-site fitness center. We provide Individual development,
on-the-job training, and development programs designed to enhance your professional growth and development while ensuring you feel valued, inspired and appreciated at work.
Jost Chemical is an equal opportunity employer and affirmatively seeks diversity in its workforce. We consider applicants, and make all employment decisions, without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, or any other legally protected status. We are committed to recruiting and retaining the best talent in the chemical manufacturing industry. Minimum Requirements High School Diploma or G. E. D. Four years of chemical, medical, or similar manufacturing
experience Knowledge & Experience Requirements Must have a quality and continuous improvement mindset.
Ability to utilize a computer, Microsoft Outlook, and Microsoft Excel. Very high attention to detail and basic math skills. Strong understanding of complex processes and technical equipment. Ability to work in a fast-paced environment while meeting productivity demands. Primary Responsibilities Reviewing and approving all batch record documentation. Ensuring all errors in batch record documentation are appropriately and promptly resolved. Printing batch record documentation requested by manufacturing. Reconciling batch record documentation. Conduct various Quality tasks in the plant environment.
Generate and maintain key performance indicators for management review. Other QA duties as needed.
with other departments regarding Receiving and Quality Control requirements. Record, Disposition and Investigate NCRs and RMAs in a timely manner. Comply with applicable Quality Management System requirements; including Quality Policy, Quality Manual, QMS Procedures, Work Instructions, Forms, Recordkeeping, etc.
Support and fully participate in QMS related activities Participate in cross-training to improve ongoing efficiency and business continuity. Maintain clean and orderly work environment. Participate in end-of-year inventory process and assist in resolution of inventory discrepancies. Perform other tasks as deemed necessary by Supervisor. Qualifications High School diploma or equivalent
education Can effectively execute the above listed duties and responsibilities without limitations Follows written and verbal directions with limited oversight Effectively communicates, reads and writes in English language Able to multi-task with frequent interruptions in a fast-paced environment Can perform and cross-train associates in detail-oriented QC inspection techniques Able to interpret QC technical drawings and diagrams Able to carefully handle fragile items and inspect under microscopic magnification Willingness to work on interdepartmental assignments as required Working conditions The job is performed at our facilities in a climate controlled non-smoking environment.
It requires
a person to work day shift and overtime as peak workload may require.
Physical requirements The job requires standing and sitting for extended lengths of time and the ability to lift and manage packages and products weighing up to 30 lbs. Direct reports None.
