Quality Lead Specialist Manufacturing / Ingénieur qualité principal Production
Core
Upholding and implementing the GE Healthcare Quality Policy & Quality Management System for medical device products at the Buc manufacturing site in France.
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, regulatory compliance (ISO 13485, 21 CFR, IEC 60601-1), internal and external audit execution, root cause analysis (fishbone, 5 Why's), CAPA process management, design transfer support, process improvement leadership
Preferred skills
Problem analysis and resolution, team consensus building, quality metric influence (training, complaint resolution), process effectiveness driving
Technologies
ISO 13485, 21 CFR, IEC 60601-1, CAPA tools, root cause analysis tools
Responsibilities
Drive compliance activities for medical device products, ensure patient safety and regulatory compliance, implement and improve the total quality management system, perform internal and support external audits, support design transfer and production teams, influence quality system metrics
Seniority
Senior, hands-on IC