Device Quality Engineer

About the role

We are seeking a Device Quality Engineer to provide end‑to‑end quality oversight for medical devices and combination products in the commercial phase. The role ensures compliance, product performance and patient safety throughout the product lifecycle, working from our manufacturing sites in Switzerland or Belgium.

Key responsibilities

• Lead quality oversight for commercial device lifecycle management, including complaint trending, deviations, CAPA and change control.
• Maintain and improve Risk Management Files and traceability documentation.
• Provide quality oversight of device suppliers and contract manufacturing organisations, conduct audits and monitor KPIs.
• Support inspections, audit readiness and regulatory interactions with global standards such as ISO 13485, EU MDR and FDA GMP.
• Monitor supplier performance and ensure compliance with Quality Agreements.

Required profile

• Solid experience in quality for medical devices or combination products.
• Strong knowledge of global regulations (ISO 13485, EU MDR, FDA, GMP).
• Proven experience in vendor and lifecycle quality management within a matrix organization.
• Professional fluency in French and English, both written and spoken.

Required skills

• ISO 13485
• EU MDR
• FDA regulations
• GMP
• Risk Management
• CAPA
• Change Control
• Auditing

What we offer

• Opportunity to work in a global biopharmaceutical company focused on neurology and immunology.
• Collaborative, inclusive culture with emphasis on continuous improvement.
• Potential to impact patient safety and product quality worldwide.