Quality Assurance Supervisor

About the role

Tegra Medical is a trusted contract manufacturer serving leading names in the medical device industry. We specialize in complex projects requiring precision and innovation. Headquartered in Franklin, MA, and part of the global SFS Group in Heerbrugg, Switzerland, we are shaping the future of healthcare.

The Quality Assurance Supervisor provides leadership for all Quality Assurance processes, supervises the Quality Assurance and Document Control teams, and supports the manufacturing process for medical device components in compliance with GDP rules and ISO 13485 and FDA requirements.

Responsibilities

• 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; evaluate 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.

Requirements

• 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.
• Education Requirements: Bachelor’s degree is desirable; associate degree with equivalent experience, or High school diploma with at least 10 years of medical device manufacturing/quality experience will be considered. Certificate in quality assurance is a plus.

Physical Requirements

• 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.

Benefits

• On-the-job training and advancement opportunities.
• Competitive hourly wage plus shift differentials (2nd & 3rd Shift).
• Health, dental, vision, life, and disability insurance; 401K and much more.
• Paid time off, sick time and holiday pay.
• Employee Assistance Program / Tuition Reimbursement.