Senior Quality Engineer
$125,000–$135,000 year
Hybrid · Billerica, Massachusetts, United States
Job Summary
Senior Quality Engineer responsible for guiding quality engineering practices across design transfer, incoming inspection, production, field returns, and data monitoring. Lead and support quality-system activities including ECOs, MV review, PLQC participation, control plans, PFMEAs, validations (IQ/OQ/PQ), data queries/reports, trend analysis, and CAPA. Ensure compliance with ISO13485, ISO14971, MDSAP, and FDA regulations; drive process improvements to enhance yield and product quality; enable cross-functional teams and maintain robust documentation and records.
Required Qualifications
- Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820)
- Experience in validations (IQ, OQ, PQ) of manufacturing/quality equipment or processes
- Experience with PFMEAs, Risk Analysis, and Validation Plans
- Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC)
- Experience performing internal audits
- Excellent written and verbal communication skills
- Detail-oriented with ability to read technical documents
- Cross-functional collaboration with multi-disciplined teams
- Proficiency with MS Word, MS Excel, MS Access; familiarity with Minitab or similar statistical software
- Experience with Master Control and/or Power BI a plus
- Six Sigma Green Belt or related certifications a plus
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