Quality Specialist Manufacturing - fixed-term contract / Ingnieur qualit production CDD (H/F)
Core
Driving a Quality culture and ensuring regulatory compliance for GE Healthcare medical device products at the BUC manufacturing site.
Role type
Quality Specialist (Manufacturing)
Builds
Medical device products for GE Healthcare
Domain
Medical Devices / Manufacturing / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance, Quality Management Systems (QMS), Risk management, Internal/External auditing, Non-conformance resolution, Supplier quality management, GMP/GLP/GDP knowledge, Incident and recall management, Process improvement, Documentation management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Pilot compliance activities for medical device products; Ensure patient safety and regulatory compliance; Implement and improve the total quality management system; Collaborate with design transfer and production teams; Participate in internal and external audits; Participate in the resolution of non-conformities and continuous process improvement; Participate in incident and recall management; Participate in supplier quality management; Participate in the management of regulatory requirements and standards (ISO, GMP, GLP, GDP, etc.).
Seniority
None stated