Quality Lead Specialist Manufacturing / Ingénieur qualité principal Production
Core
Upholding and implementing the GE Healthcare Quality Policy & Quality Management System for the Buc Manufacturing site in France to ensure patient safety and regulatory compliance.
Role type
Principal 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 auditing, non-conformance management, corrective action planning, regulatory compliance (ISO 13485), process validation, supplier quality management, risk reduction, performance indicator definition, cross-functional collaboration
Preferred skills
Continuous improvement methodologies, digital transformation initiatives, stakeholder communication, training and development
Technologies
ISO 13485, QMS software platforms
Responsibilities
Lead product continuity activities for design transfer and production teams; conduct internal audits and manage non-conformities; ensure compliance with European and global regulations; support external audits and regulatory inspections; define and track quality performance indicators; manage supplier and subcontractor quality compliance; coordinate incident and delay management; drive continuous improvement of quality processes and culture.
Seniority
Principal, hands-on IC with strategic oversight