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Engineering
Senior NPI Quality Engineer
Radiant System, IncIrvine, CA🇺🇸United StatesPosted 31 Jul 2026
Quick Overview
Work Type
Hybrid
Level
Mid Senior
Job Description
- 5+ years of Quality Engineering experience in the Medical Device industry
- Strong experience with New Product Introduction (NPI) and Design Transfer
- Hands-on experience with Risk Management (PFMEA/FMEA, ISO 14971)
- Develop and improve inspection processes and support First Article Inspection (FAI)
- Experience with Validation (IQ/OQ/PQ), PPAP, and Process Validation
- Collaborate with R&D, Manufacturing, and Quality teams throughout the product lifecycle
- Knowledge of ISO 13485, CAPA, NCR, and GMP is preferred
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