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Sr. Quality Engineer

Company: Oxenham Group LLC
Location: Burlington
Posted on: January 27, 2023

Job Description:

Job Title: Sr. Quality Engineer

Job Description: Our client is a Medical Device Company specializing in Vascular devices. The company is looking for a Sr. Quality Engineer. The position will be the subject matter expert for Corrective and Preventative Actions (CAPAs) sitewide.

Job Duties:

  • Manage the CAPA program including:

  • Assigning new CAPAs,
  • Following up on open CAPAs
  • Completing effectiveness checks on completed CAPAs

  • Author and improve QMS SOPs
  • Update QMS based on new quality standards, improving QMS processes as needed using Master Control QMS software
  • Support internal and external audits from regulatory agencies updating the QMS as needed based on findings


    • Bachelors Degree (STEM preference)
    • 7 years in an ISO 13485 environment

Keywords: Oxenham Group LLC, Boston , Sr. Quality Engineer, Engineering , Burlington, Massachusetts

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