Quality Assurance Supervisor

Tegra Medical; Franklin (MA); On-site; USD 39,000 - 83,000; Full time

Benefits offered by this job

On-the-job training

Shift differentials (2nd/3rd shift)

Health, dental, vision, life, and 401K

Job summary

Tegra Medical, a trusted contract manufacturer in Franklin, MA, seeks a Quality Assurance Supervisor to lead QA and Document Control, ensuring compliance with ISO 13485 and FDA QSR requirements. You will support manufacturing processes and mentor QA staff while maintaining rigorous quality records and regulatory readiness.

The role emphasizes leadership, regulatory expertise, and process improvement across the QA function within a medical device environment.

Qualifications

• Minimum 5 years in Quality Assurance in a manufacturing environment with a certified quality system.
• Experience supervising employees or leading teams.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GDP and related regulatory requirements.

Responsibilities

• Lead and supervise QA and Document Control teams; develop policies and standards.
• Manage site audit program and support customer, internal, and regulatory audits.
• Ensure quality records and documentation are accurate and reviewable.
• Support quality system management and regulatory compliance requests.
• Provide expertise for continuous improvement in QA processes.
• Perform QA and Document Control tasks to support daily operations.

Skills

Leadership experience

FDA 21 CFR 820 knowledge

ISO 13485 knowledge

Quality reporting

Documentation control

Education

Bachelor’s degree desirable

Associate degree with equivalent experience

High school diploma + 10 years experience

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

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.

Job Summary

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.

Role and 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 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.

Qualifications

• 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, orHigh 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

What We Offer:

• 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