Sr Manufacturing Quality Engineer
$79,000–$127,650 year
On-site · Danvers, Massachusetts, United States
Job Summary
Senior-level Sr Manufacturing Quality Engineer with responsibility for quality engineering support across development and manufacturing of medical device equipment and facilities. Lead quality reporting (KPIs, goals, objectives) for capital products; manage Material Review Board activities; drive non-conformance investigations and CAPA; validate manufacturing processes (IQ/OQ/PQ) for facility expansion; collaborate on process controls, DOE, risk management, and SOP development; ensure GMP/compliance per FDA QSRs, ISO13485, ISO14971; travel up to 10% and on-site in Danvers, MA.
Required Qualifications
- Bachelor's degree in a relevant Engineering field
- 2-4 years of experience in Quality Assurance/Quality Engineering (QA/QE) in the medical device field
- Good understanding of FDA QSRs, ISO13485, ISO14971
- Experience with handling non-conforming material and assemblies, including root cause investigations
- Experience with qualification of production equipment and validation of production processes
- Role requires on-site presence in Danvers, MA with up to 10% travel
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