Quality Engineer

  • location: Marlborough, MA
  • type: Permanent
  • salary: $65,000 - $80,000 per year

job description

Quality Engineer

Permanent position: Quality Systems Engineer needed in the Hudson, MA area for immediate consideration. The right person supports external quality audits and leads/supports internal quality audit teams to assure that site activities comply with all applicable regulatory requirements, policies and procedures. Must have a BS in Science, Health, or Engineering along with 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) along with experience working to interpret and apply quality regulations and standards. Apply now

Responsibilities for the Quality Engineer

  • Maintaining internal process for continuous compliance with corporate / global quality system and external requirements
  • Communication and documentation of internal and external compliance-related information including changes in external requirements, corporate requirements, and local changes to ensure continuous compliance
  • Involved in handling audit non-conformances, evaluating impact to compliance, and facilitating sustainable fixes
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
Requirements for the Quality Engineer

  • BS in Science, Health, or Engineering
  • 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) experience
  • Experience working to interpret and apply quality regulations and standards.
  • Previous accreditation as quality auditor (e.g. ASQ CQA, etc)
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