Quality Engineer II
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
COMPLETE JOB DESCRIPTION
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