INGENIEUR QUALITE - SMQ F/H
Core
Pilot, maintain, and improve the Quality Management System (QMS) for Getinge France, covering sites in Ardon and Massy, ensuring compliance with group standards and applicable regulations.
Role type
Quality Management System Engineer (Medical Devices)
Builds
Quality management system documentation and processes for medical device distribution
Domain
Medical technology / Healthcare equipment
Deliverable
dashboards & analysis
Required skills
QMS management, ISO 9001:2015, ISO 13485:2016, CAPA management, internal and external audits, supplier qualification, KPI tracking, process approach, documentation management
Preferred skills
Medical devices or pharmaceutical industry experience, ISO auditor certification, fluent English (written and spoken)
Responsibilities
Harmonize the QMS across sites, manage the quality documentation system, plan and participate in internal and external audits, track CAPAs and non-conformities, qualify suppliers, collect and monitor quality KPIs, support departments with quality and regulatory matters
Seniority
Mid-level (3 years experience)