Senior Engineer, Product Quality
Core
Ensure product quality compliance with GMP and ISO standards, manage supplier quality issues, and lead non-conformance handling for manufacturing processes.
Role type
Senior Quality Engineer (Manufacturing/Regulatory)
Builds
Production processes and quality assurance systems for medical devices
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, ISO standards, PPAP, FMEA, MSA, process control plans, SPC, supplier quality management, non-conformance analysis, regulatory guideline development, audit participation, Lean philosophy implementation, product release/rejection authority
Preferred skills
Supplier change review, new project quality setup (SPPAP), cross-functional collaboration with manufacturing and engineering
Technologies
Excel
Responsibilities
Stop processing and lead handling for non-conforming products, define and approve inspection/testing standards, train staff on quality regulations, participate in internal/external audits, manage supplier quality performance and issues, liaise with manufacturing and engineering on material quality
Seniority
Senior, hands-on IC
