Join Our Team at Tegra Medical!
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, 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
What We Offer:
- On-the-job training and advancement opportunities
- Competitive hourly wage + shift differentials (2nd & 3rd Shift)
- 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
Skills Required
- Experience supervising employees or leading team members
- At least 5 years of Quality Assurance experience in a manufacturing environment with a certified quality system
- Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GDP, and applicable regulatory requirements
- Experience with quality reporting
- Strong verbal and written communication skills
- Strong attention to detail and organizational skills
- Ability to manage multiple responsibilities and a large variety of documents
- Experience with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
- Bachelor's degree
- Associate degree with equivalent experience
- High school diploma with at least 10 years of medical device manufacturing or quality experience
- Certificate in Quality Assurance
- Ability to work regular hours in the office and meet physical requirements, including standing, PPE use, and occasional lifting up to 40 pounds
What We Do
Tegra Medical is an end-to-end contract manufacturing solutions provider, known as the company “where medical devices come to life.” Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. Our headquarters is in Franklin, Massachusetts and we have manufacturing locations in Massachusetts, Mississippi, Costa Rica, Europe, and Asia. We are ISO 13485 and FDA registered. Tegra Medical is a member of SFS. We often have open job positions for skilled manufacturing positions. Please see https://www.tegramedical.com/careers/ for our latest job openings.
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