Quality Engineer - NPI Programs
Core
Establish and execute quality strategies for pilot line operations, ensuring prototype and pilot builds are well-controlled and enable successful progression to clinical builds and commercial scale.
Role type
Quality Engineer (NPI Programs)
Builds
Prototype, pilot, clinical, and pre-commercial manufacturing builds for medical devices
Domain
Medical Devices / New Product Introduction (NPI)
Required skills
inspection plan development, risk management (DFMEA/PFMEA), design control compliance, root cause analysis, CAPA implementation, equipment/process validation (IQ/OQ/PQ), statistical analysis, process capability studies
Preferred skills
medical device industry experience, new product development (NPD) program support
Technologies
FDA QSR (21 CFR 820), ISO 13485, Design History File (DHF), Device History Record (DHR), metrology systems
Responsibilities
Lead quality engineering activities for prototype and pilot manufacturing builds; Develop and maintain inspection plans, control plans, and quality standards; Analyze quality data to identify trends and mitigate risks; Lead investigations of nonconforming materials and products; Support qualification and validation of manufacturing equipment and processes; Partner with R&D and Manufacturing Engineering to improve manufacturability and process capability.
Seniority
Mid-level, hands-on IC
