Global Device Quality Engineer – Lifecycle & Compliance

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

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.