Responsable Assurance Qualite (CDD) - Region Quality Assurance Leader (fixed-term) – FBL&IB
Core
Lead and coordinate Quality Assurance activities for a strategic cluster of European countries (France, Belgium, Luxembourg, Spain, Portugal) in the medical device industry.
Role type
Regional Quality Assurance Leader
Builds
Quality Management System (QMS) compliance and operational quality standards for medical device markets
Domain
Medical device / Healthcare / Regulated industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) management, ISO 13485 knowledge, internal and external audit leadership, CAPA process management, regulatory compliance, supplier quality oversight, deviation/concession management, training program management
Preferred skills
Advanced degree (MSc/MBA), professional certifications (ASQ CQA, Lead Auditor), regional QA leadership experience, CRM and field service quality experience, cultural agility
Technologies
CRM systems, digital tools
Responsibilities
Implement and maintain the Quality Management System (QMS), support internal and external audits including regulatory inspections, drive the CAPA process, manage deviation/concession processes, support channel partner quality oversight, collaborate with Supplier Quality team, represent the region in global QA forums
Seniority
Senior, hands-on IC
