Quality Engineer — Injection Molding - California
3 days ago
Job summary
This Quality Engineer serves as the technical lead supporting two medical device manufacturing facilities ensuring strict compliance with ISO 13485 and FDA 21 CFR 820 requirements.
Key Responsibilities include leading complex NC/CAPA investigations using structured root cause methodologies developing and executing IQ/OQ/PQ validations establishing and managing SPC alert thresholds overseeing Computer System Validation (CSV) for eQMS and production software managing supplier quality conducting MSA / Gage R&R process capability studies providing the Quality Voice in DFM design reviews supporting regulatory submissions acting as gatekeeper for tooling equipment validation release providing technical leadership training QA technicians resolving floor quality issues improving inspection efficiency.
- Bachelor's degree in Engineering (or equivalent experience)
- 4–7+ years in a medical device or FDA-regulated manufacturing environment
- Expert knowledge of ISO 13485 FDA 21 CFR 820 GD&T MSA
- Proficiency with Minitab SolidWorks ERP eQMS systems
Job description
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