Ingénieur Qualité
Core
Ensure quality of products, processes, and changes in a regulated medical device manufacturing environment.
Role type
Quality Engineer
Builds
compliant medical device products and validated processes
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance (FDA, ISO 13485, GMP), non-conformance and CAPA management, audit execution, root cause analysis, KPI tracking, process validation, supplier management, risk management
Preferred skills
medical device industry experience, Trackwise proficiency, English fluency
Technologies
Trackwise, NC-CAPA tools
Responsibilities
Pilot quality performance for industrial operations; manage internal and supplier non-conformities and CAPAs; participate in internal and external audits; drive continuous improvement initiatives; analyze and measure quality indicators; support product lifecycle validations and qualifications; foster quality culture through training and best practices
Seniority
Mid-level (3-5 years experience)