Quality Engineer II

Job is Expired
Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Mon, Jul 29, 2024

Job Summary

A company is looking for a Quality Engineer II in Lexington, Massachusetts.

Key Responsibilities:
  • Investigating manufacturing problems and product complaints to determine root cause and recommend corrective actions
  • Maintaining quality system information databases and preparing reports to monitor business trends
  • Supporting engineering in product development, testing, and commercialization

Required Qualifications:
  • Bachelor's degree in Biomedical Engineering or related field with 5 years of experience, or Master's degree with 3 years of experience in medical device quality engineering
  • Experience with ISO14971, 21 CFR Part 820, and ISO 13485
  • Proficiency in Nonconforming Material Reports, Root Cause Analysis, and CAPAs
  • Familiarity with risk analysis, DFMEA, Design Verification, and test method validation
  • Experience with procedural gap analysis and Change Control review

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