Quality Lead Specialist Manufacturing / Ingnieur qualit principal Production
Core
Uphold and implement the GE Healthcare Quality Policy & Quality Management System at the Buc manufacturing site in France, ensuring patient safety and regulatory compliance for medical device products.
Role type
Lead Quality Engineer (Manufacturing)
Builds
Medical device products for GE Healthcare
Domain
Medical technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) implementation, internal and external auditing, root cause analysis, CAPA management, regulatory compliance knowledge, process improvement, design transfer support
Preferred skills
Root cause analysis tools (fishbone, 5 Why's), team leadership, communication skills, problem-solving
Technologies
ISO 13485, 21 CFR, IEC 60601-1
Responsibilities
Create a Quality culture by driving compliance activities for GEHC medical device products; Ensure ongoing patient safety and regulatory compliance; Perform internal audits and support external audits; Promote product and process improvements through root cause analysis and CAPA; Support design transfer and production teams over the product lifecycle; Influence quality system metrics such as Corrective and Preventive Action and complaint resolution metrics
Seniority
Senior, hands-on IC