Device Quality Engineer

UCB; Bulle; Vor Ort; CHF 80.000 - 120.000; Vollzeit

Zusammenfassung

UCB in Bulle, Switzerland is seeking a Device Quality Engineer to provide quality oversight for medical devices and combination products. Your responsibilities will include risk management, vendor quality oversight, and ensuring compliance with regulations like ISO 13485 and EU MDR.

This role demands strong analytical skills and the ability to work cross-functionally in a global environment. Bilingualism in French and English is required. This is an opportunity to impact patient safety while driving continuous quality improvement.

Qualifikationen

• 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.

Aufgaben

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

Kenntnisse

Quality management for medical devices

Regulatory knowledge (ISO 13485, MDR, FDA, GMP)

Vendor management

Analytical skills

Problem-solving

Communication skills

Data-driven decision making

Languages (French, English)

Jobbeschreibung

Make your mark for patients. We are looking for a Device Quality Engineer to join our Devices & Primary Pack Quality team at Bulle, Switzerland or Braine l'Alleud, Belgium.

About the Role

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 (written and spoken).

Equal Opportunity Statement

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