Product Quality Engineer
Core
Lead design controls, quality management, and risk integration for medical device development, transfer, and sustaining initiatives.
Role type
Senior Product Quality Engineer (Medical Devices)
Builds
Design History Files, Quality Plans, Risk Management processes, and regulatory submissions for medical devices.
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Quality Management, ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, IEC 62304, Data Analysis, Design for Quality (DFQ), Root Cause Analysis (RCA), CAPA, Regulatory Requirements, Technical Documentation, Product Lifecycle Management (PLM), Defect Management, Design Verification Planning, Design Validation Planning, Product Test Design
Preferred skills
Six Sigma Green Belt, People Management
Technologies
ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, IEC 62304
Responsibilities
Lead Design Controls and Design History Files, Drive Quality norms for design engineering projects, Integrate Risk Management processes throughout the product lifecycle, Lead Quality Plan initiatives, Support Regulatory Affairs submissions, Lead Corrective and Preventive Actions (CAPA), Transfer Quality deliverables to manufacturing and supplier quality teams, Support internal and external audits.
Seniority
Senior, hands-on IC
