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Device Quality Engineer

UCB -
Eigenbrakel

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Vacaturegegevens

Vaste Jobs

Kwalificaties

Frans
Communicatieve vaardigheden
FDA-regulaties

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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 Braine l'Alleud, Belgium or Bulle, Switzerland.

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 You will collaborate in a highly cross-functional environment including:

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.

Interested? For this role we’re looking for the following education, experience and skills

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!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

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

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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eu regulatory vacatures in diegem, vlg

Device Quality Engineer

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Director, EU Public Affairs

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Legal Researcher / Postdoctoral Researcher in Digital Health Law, Artificial Intelligence and Health Data Governance

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Associate Partner - Governance

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Manager Total Rewards

Sales Manager – GDPR & AI Act Compliance SaaS

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Compensation & Benefits Manager

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AI Security Specialist

Contract Expert Flexibility & Ancillary Services

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