Device Quality Engineer

UCB S.A.; Bulle; Vor Ort; CHF 80.000 - 100.000; Vollzeit

Zusammenfassung

UCB S.A. is seeking a Device Quality Engineer in Bulle, Switzerland. You will provide quality oversight for medical devices and combination products, ensuring compliance and patient safety throughout the product lifecycle. The role involves collaborating with global Quality teams and managing vendor quality oversight.

Ideal candidates possess solid experience in medical device quality, knowledge of ISO regulations, and strong problem-solving skills. Proficiency in French and English is required.

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, including audits.

Kenntnisse

Quality management for medical devices

Knowledge of ISO 13485

Vendor quality management

Analytical and problem-solving skills

Professional proficiency in French

Professional proficiency in English

Jobbeschreibung

Make your mark for patients

We are looking for a Device Quality Engineer, who is quality-driven, collaborative, impact-oriented and eager to join our Devices & Primary Pack Quality team, based in our manufacturing site in 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

This is a global role with strong interfaces across regions and external partners.

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.

Desired 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).

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

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