JVT Advisors

Senior QA Engineer

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Location: Marlboro, Massachusetts 01752
Employment Type: Contract

Job Description

Contract length:  12 Months

Responsibilities:

  • 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

Requirements:

  • 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

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Justin McKay

Principal Life Sciences Recruiter

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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