Device Quality Engineer — Global Lifecycle & Compliance

UCB S.A.; Eigenbrakel; Hybride; EUR 65 000 - 85 000; Plein temps

Résumé du poste

UCB S.A. is seeking a Device Quality Engineer based in Braine l'Alleud, Belgium or Bulle, Switzerland, to provide end-to-end quality oversight for medical devices and combination products during the commercial phase. Your role will ensure compliance, product performance, and patient safety throughout the product lifecycle.

You will lead quality management activities, drive complaint handling, and oversee vendor quality compliance with global standards. The ideal candidate will possess solid experience in medical device quality assurance and proficiency in both French and English.

Qualifications

• Solid experience in quality for medical devices or combination products.
• Strong knowledge of global regulations (ISO 13485, MDR, FDA, GMP).
• Proven experience in vendor and lifecycle quality management.

Responsabilités

• Lead quality oversight for commercial device lifecycle management activities.
• Drive complaint trending, deviations, CAPA, and change control processes.
• Provide quality oversight of device suppliers including audits.

Connaissances

Quality for medical devices

Global regulations knowledge (ISO 13485, MDR)

Vendor quality management

Cross-functional collaboration

Analytical and problem-solving skills

Data-driven decision-making

Languages: French and English

Description du poste

UCB S.A. is seeking a Device Quality Engineer based in Braine l'Alleud, Belgium or Bulle, Switzerland, to provide end-to-end quality oversight for medical devices and combination products during the commercial phase. Your role will ensure compliance, product performance, and patient safety throughout the product lifecycle.

You will lead quality management activities, drive complaint handling, and oversee vendor quality compliance with global standards. The ideal candidate will possess solid experience in medical device quality assurance and proficiency in both French and English.