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Senior Quality Engineer, Private Label

Location: Boston, Massachusetts, United States
Reference ID:

Our client is a world leader in medical technology; offering innovative solutions in surgical instrumentation, neurosurgery, reconstructive, and general surgery for over 30 years.  We are supporting them for a Senior Quality Engineer, Private Label to provide quality engineering support for private label products, including audits/assessments, inspection technique support, verification/validation activities, CAPA/SCAR and change management.  FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.

The Right Talent:

BS in Engineering, Life Science, or a related technical discipline is required.  Equivalent combination of education and experience will also be considered.

5+ years professional work experience in a GMP and/or ISO regulated industry is required.

Experience or knowledge with tissue based medical devices and experience with collagen based manufacturing processes highly preferred.

Auditor Certification to ISO 13485:2016 strongly preferred.

Knowledge of medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820.

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