Quality Assurance Supervisor
Tegra Medical
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Benefits offered by this job
Job summary
The Quality Assurance Supervisor at Tegra Medical will lead QA processes and document control in full compliance with ISO 13485 and FDA requirements. You will supervise QA and Document Control teams and support the manufacturing process for medical device components in accordance with GDP rules and regulatory standards.
Applicants should have 5+ years in QA within a manufacturing setting, solid knowledge of FDA/ISO requirements, and strong communication and organizational skills.
Qualifications
- Experience supervising employees or leading team members.
- Minimum of 5 years in a Quality Assurance function in manufacturing with a certified quality system.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GDP and related regs.
- Experience in Quality Reporting.
- Excellent verbal and written communication with attention to detail.
- Ability to present information clearly in one-on-one and small groups.
- Well organized with ability to manage multiple documents and tasks.
- Proficient with Word, Excel, PowerPoint, and Adobe Acrobat.
Responsibilities
- Lead development and execution of QA and document control processes per ISO 13485 and FDA QSR.
- Recruit, train, and supervise QA and Document Control teams; manage staff development.
- Ensure Tegra Medical Quality Records and docs are consistent for internal, customer, and regulatory reviews.
- Support the site audit program and Quality Management during customer, internal, and regulatory audits.
- Ensure compliance with QA processes and Quality System management; drive efficiency improvements.
- Perform QA and Document Control tasks to support daily operations.
- Carry out other duties to support the Quality team.
Skills
Education
Tools
Job description
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
FT Salary Full Time Franklin, MA, US
13 days ago Requisition ID: 1169
Salary Range: $96,000.00 To $120,000.00 Annually
We’re a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others can’t, we pride ourselves on precision and innovation. Headquartered in Franklin, MA, Tegra Medical is part of the global SFS Group, based in Heerbrugg, Switzerland. Together, we’re shaping the future of healthcare.
The Quality Assurance Supervisor provides leadership for all Quality Assurance processes in compliance with the medical device regulatory requirements, supervises the Quality Assurance and Document Control teams, and supports the manufacturing process for medical device components for all GDP rules and ISO 13485 and FDA requirements.
- Support and maintain the development and execution of quality assurance and document control processes, policies, or standards in compliance with medical device regulatory requirements per ISO 13485 and FDA QSR (21 CFR 820).
- Support, recruit, train, and supervise the Quality Assurance and Document Control teams, including recommendations related to manpower requirements and personnel development/promotions to include, evaluating staff's career development plans through periodic reviews and provide mentoring to improve staff effectiveness and skills.
- Ensure all Tegra Medical Quality Records and documentation are reviewed for consistency and are appropriate for internal, customer, and regulatory body review.
- Manage and support the site audit program, which includes supporting Quality Management during all customer, internal, and regulatory body audits.
- Support and ensure compliance with Quality Assurance processes, Quality System management, and customer regulatory compliance requests.
- Provide expertise and support for all Quality Assurance and Document Control processes as required, including implementation of efficiency improvements.
- Perform Quality Assurance and Document Control tasks as needed to support daily department function.
- Perform other duties as assigned to support the Quality team.
- Experience supervising employees or leading team members.
- Minimum of 5 years working in a Quality Assurance function in a manufacturing environment with a certified quality system.
- Good knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GDP and other regulatory requirements as applicable to document control functions.
- Experience in Quality Reporting.
- Ability to communicate well (verbal & written) and with strong attention to detail.
- Ability to write simple correspondence and effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
- Must be well organized, able to manage multiple responsibilities and a large variety of documents.
- Experience with software such as: Microsoft Word, Excel, PowerPoint, and Adobe Acrobat .
Bachelor’s degree is desirable, associate degree with equivalent experience, orHigh school diploma with at least 10 years of medical device manufacturing/quality experience will be considered.Certificate in quality assurance is a plus.
- Frequent performing repetitive work
- Occasional lifting (max. 40 lbs.)
- Occasional carrying (max. 40 lbs.)
- Subject to physical hazards from moving equipment and machine parts
- Constant safety glasses
- Constant full PPE
- Frequent standing
- Occasional sitting, walking, pushing, pulling, reaching
- Regular attendance in the office is required
- On-the-job training and advancement opportunities
- Competitive hourly wage + shift differentials(2nd& 3rdShift)
- Great benefits like health, dental, vision, life, and disability insurance; 401K and much more.
- Paid time off, sick time and holiday pay
- Employee Assistance Program/ Tuition Reimbursement
We’re a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others can’t, we pride ourselves on precision and innovation. Headquartered in Franklin, MA, Tegra Medical is part of the global SFS Group, based in Heerbrugg, Switzerland. Together, we’re shaping the future of healthcare.
The Quality Assurance Supervisor provides leadership for all Quality Assurance processes in compliance with the medical device regulatory requirements, supervises the Quality Assurance and Document Control teams, and supports the manufacturing process for medical device components for all GDP rules and ISO 13485 and FDA requirements.
- Support and maintain the development and execution of quality assurance and document control processes, policies, or standards in compliance with medical device regulatory requirements per ISO 13485 and FDA QSR (21 CFR 820).
- Support, recruit, train, and supervise the Quality Assurance and Document Control teams, including recommendations related to manpower requirements and personnel development/promotions to include, evaluating staff's career development plans through periodic reviews and provide mentoring to improve staff effectiveness and skills.
- Ensure all Tegra Medical Quality Records and documentation are reviewed for consistency and are appropriate for internal, customer, and regulatory body review.
- Manage and support the site audit program, which includes supporting Quality Management during all customer, internal, and regulatory body audits.
- Support and ensure compliance with Quality Assurance processes, Quality System management, and customer regulatory compliance requests.
- Provide expertise and support for all Quality Assurance and Document Control processes as required, including implementation of efficiency improvements.
- Perform Quality Assurance and Document Control tasks as needed to support daily department function.
- Perform other duties as assigned to support the Quality team.
- Experience supervising employees or leading team members.
- Minimum of 5 years working in a Quality Assurance function in a manufacturing environment with a certified quality system.
- Good knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GDP and other regulatory requirements as applicable to document control functions.
- Experience in Quality Reporting.
- Ability to communicate well (verbal & written) and with strong attention to detail.
- Ability to write simple correspondence and effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
- Must be well organized, able to manage multiple responsibilities and a large variety of documents.
- Experience with software such as: Microsoft Word, Excel, PowerPoint, and Adobe Acrobat .
Bachelor’s degree is desirable, associate degree with equivalent experience, orHigh school diploma with at least 10 years of medical device manufacturing/quality experience will be considered.Certificate in quality assurance is a plus.
- Frequent performing repetitive work
- Occasional lifting (max. 40 lbs.)
- Occasional carrying (max. 40 lbs.)
- Subject to physical hazards from moving equipment and machine parts
- Constant safety glasses
- Constant full PPE
- Frequent standing
- Occasional sitting, walking, pushing, pulling, reaching
- Regular attendance in the office is required
- On-the-job training and advancement opportunities
- Competitive hourly wage + shift differentials(2nd& 3rdShift)
- Great benefits like health, dental, vision, life, and disability insurance; 401K and much more.
- Paid time off, sick time and holiday pay
- Employee Assistance Program/ Tuition Reimbursement
Monday to Friday, Standard Working Hours
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