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Quality Engineer

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$95,000-$107,500  •  Franklin, MA
•  Direct Hire
•  Job Number:275016
•  Posted:10/30/2026

$100-$110K

Responsibilities

  • Support the maintenance and effectiveness of the QMS
  • Provide shop-floor support to troubleshoot and improve production uptime and quality
  • Own CAPA and MRB processes; lead associated investigations and actions
  • Support equipment qualification, validation, IQ/OQ/PQ as needed
  • Draft and edit procedures, work instructions, and forms
  • Assist with internal/external audits and regulatory inspections

Requirements

Qualifications

  • Understanding of a QMS and ISO13485:2016 compliance requirements
  • Experience with CAPA, NCMR, FAI and related quality processes
  • Experience in medical device manufacturing preferred, with metrology proficiency
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