Quality Engineer
Core
Leads technical quality engineering and validation activities for new product development, sustaining engineering, and manufacturing to ensure regulatory and customer compliance.
Role type
Quality Engineer (Regulated Industry)
Builds
Validated equipment, processes, and systems for medical devices
Domain
Medical Devices / Manufacturing
Required skills
Validation protocols (IQ/OQ/PQ), Risk management (FMEA), Statistical analysis (DOE, capability analysis), Root cause analysis, Regulatory compliance (ISO, GMP), Technical writing, Cross-functional collaboration
Preferred skills
Quality Engineer certification, Experience with eQMS/ERP (MasterControl, Oracle), Supplier quality audits
Technologies
MasterControl, Oracle, Microsoft Office
Responsibilities
Develop and execute validation protocols for equipment and processes; Lead investigations for nonconformances and CAPAs; Apply statistical tools to assess risk and improve processes; Partner with R&D and Manufacturing to maintain quality requirements; Provide technical guidance to junior associates.
Seniority
Mid-level, hands-on IC