Senior QA EngineerApply Now
Location: Marlboro, Massachusetts 01752
Employment Type: Contract
- Participates in ensuring that the implementation, effectiveness and integrity of quality system is compliant to all applicable standards and regulations
- Performs gap assessments between Quality System procedures and EU Medical Device Regulation
- Develops and implements procedures, forms and/or templates to assure compliance with Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other International regulatory requirements.
- Reviews and approves quality system document changes for Quality requirements and compliance to applicable regulations
- Bachelor’s degree or equivalent combination of education and experience.
- Seven to ten years related experience in an FDA regulated industry with at least five years recent experience in Medical Devices or equivalent combination of education and experience
- Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical Device Directive, EU Medical Device Regulation (in particular)
- Lead Auditor experience
- Experience with Agile Product Lifecycle Management system a plus
With extensive industry experience and specializing in our Life Sciences & Technologies practice area, Justin enjoys helping candidates find their next perfect employment opportunity.
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