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Design Quality Assurance Engineer

Biomedical Search

Gardner, MA

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JOB DETAILS
SKILLS
Aerospace and Defense, Code of Federal Regulations, Cross-Functional, Detail Oriented, Documentation, Engineering, FDA (Food and Drug Administration), File Audits, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Medical Equipment, Product Development, Product Support, Quality Assurance, Quality Engineering, Regulations, Risk Management, Team Player
LOCATION
Gardner, MA
POSTED
30+ days ago
Job Description: We are seeking a Design Quality Assurance Engineer to support product development programs in regulated industries including medical device, aerospace, and defense.This role partners closely with engineering teams to ensure all design and development activities meet regulatory and quality requirements from concept through production.What You’ll Do:
  • Ensure compliance with Design Controls (FDA, ISO 13485) throughout development
  • Review and approve design documentation (inputs, outputs, V&V, changes)
  • Maintain and audit Design History Files (DHF)
  • Support risk management and design transfer to manufacturing
  • Participate in design reviews and guide engineering teams on quality requirements
What We’re Looking For:
  • 5+ years of quality engineering experience in regulated environments
  • Strong knowledge of Design Controls, DHF, and product development processes
  • Experience with ISO 13485, FDA 21 CFR Part 820, and risk management (ISO 14971)
  • Collaborative, detail-oriented, and comfortable working cross-functionally

About the Company

B

Biomedical Search

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