What are the responsibilities and job description for the Senior NPI Quality Engineer position at Radiant System?
- 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