Device Quality Engineer

UCB


Job Location:

La Gruyère - Switzerland

Monthly Salary: Not Disclosed
Posted on: 6 days ago
Vacancies: 1 Vacancy

Job Summary

Make your mark for patients

We are looking for aDevice 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 lAlleud Belgium.

About the role

As a Device Quality Engineer you will provide endtoend 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 youll 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 youll 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 were 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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.


Required Experience:

IC

Make your mark for patientsWe are looking for aDevice 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 lAlleud Belgium.About the roleAs a Device Quality Engine...

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UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more

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