Device Quality Engineer

UCB S.A.; Eigenbrakel; Sur place; 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

Device Quality Engineer – Braine l'Alleud, Belgium or Bulle, Switzerland

As a Device Quality Engineer, you will provide end‑to‑end quality oversight for medical devices and combination products in the commercial phase. You will ensure compliance, product performance, and patient safety throughout the entire product lifecycle. You will drive lifecycle management, risk management, and vendor quality oversight while ensuring alignment with global standards such as ISO 13485, EU MDR, and UCB Corporate Quality requirements.

Who you’ll work with

• Global and regional Quality teams
• Medical Devices Technical Solution Teams (TST)
• Regulatory Affairs
• Vendor and CMO partners
• Internal stakeholders across supply, manufacturing, and quality systems

What you’ll do

• Lead quality oversight for commercial device lifecycle management activities.
• Drive complaint trending, deviations, CAPA, and change control processes.
• Maintain and continuously improve Risk Management Files (RMF) and traceability.
• Provide quality oversight of device suppliers and CMOs, including audits and KPIs.
• Support inspections, audit readiness, and regulatory interactions.
• Monitor supplier performance and ensure quality agreement compliance.

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.
• Ability to work cross‑functionally in a global, matrix organization.
• Strong analytical, problem‑solving, and communication skills.
• Continuous improvement mindset with a focus on data‑driven decisions.
• Languages: French and English at a professional level (both written and spoken).

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

To request reasonable accommodation, contact [e-mail].