QA Supervisor – Medical Devices & Documentation

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

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.