Device Quality Engineer: Lifecycle & Compliance Leader

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

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.