Quality Lead Specialist / Spécialiste qualité principal (H/F)
Core
Uphold and implement the Quality Management System (QMS) for GE Healthcare medical devices at the Buc manufacturing site in France, ensuring patient safety and regulatory compliance.
Role type
Quality Lead Engineer / Site Quality Leader
Builds
Medical device products (design transfer and production continuity)
Domain
Medical technology / Regulatory Quality Assurance
Deliverable
client delivery
Required skills
Root cause analysis, CAPA process management, internal/external audit execution, QMS maintenance and deployment, risk assessment and escalation, strategic direction definition
Preferred skills
Design transfer management, production line support, non-conforming product focal point, process improvement leadership
Technologies
ISO 13485, 21 CFR, IEC 60601-1
Responsibilities
Create a quality culture by driving compliance activities; Ensure ongoing patient safety and regulatory compliance; Perform internal audits and support external audits; Assess, escalate, and contain quality, safety, or compliance risks; Act as the primary contact with auditors during external audits and regulatory inspections; Oversee and manage all Quality Assurance activities on-site including CAPA, audits, inspections, and training.
Seniority
Senior, hands-on IC with site leadership responsibilities