Make your mark for patients

 

To strengthen our Devices and Wearable Tech Quality department we are looking for a talented profile to fill the position of: Device Development Quality Lead – Braine l’Alleud, Belgium

 

About the role

This global role leads to operational Quality Assurance for the development and commercialization of medical devices, combination products, and primary packaging, both internally and with key vendors. It also provides internal QA consultancy and ensures compliance with MDR, ISO standards, and GMP/cGMP requirements through close collaboration with vendor QA teams and UCB Technical Operations.

 

You will work with

This role collaborates closely with QA management at vendor sites, UCB Technical Operations, and various internal teams. It serves as a key liaison between external vendors involved in the design, development, and manufacturing of medical devices, combination products, and primary packaging, and internal stakeholders such as Corporate QA teams. The position also works in partnership with affiliate and operational teams to ensure effective QA service delivery and regulatory compliance across global activities.

 

What you will do

 

 Design and development Quality assurance

Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as requiredReview and approve protocols and reports for Verification & Validation studies, technology transfers, stability studiesReview and approve UCB documentation. Ensure Design History File (DHF) is in placeEnsure deliverables are issued in accordance with the D&D plan

 

Vendor quality management

Accommodate design & technology transfer and ensure systems alignment between vendor and UCBPerforming focused assessments/auditsPreparation and negotiation of Quality AgreementsEnsure systems alignment between vendor and UCBSupport risk register for the vendor, and follow up on mitigation activitiesOversee inspection plans at CMO and UCB

 

Quality processes

Facilitate investigations and resolution of issues relating to deviation and change managementReview and approve deviationsTrack CAPA events and closureOversee/track change controlsAct as the Operational QA link between selected external vendors within the Medical Device and primary packaging portfolioAssist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure

 

General GMP

Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant mannerDrive/Support projects related to quality system improvementMaintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices, Combination Products and primary packaging activitiesMaintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA and Primary packaging departments in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments

 

Interested? For this position you’ll need the following education, experience and skills

A master’s degree in a relevant scientific discipline is requiredA minimum of 3 years’ experience in the Medical Devices sector, ideally in quality assuranceUS and EU knowledge of pharmaceutical and medical devices regulations together

with quality principles and techniques.

Fluency in English (oral and written) is essential; French is a strong assetDemonstrates accountability in decision-making and follow-throughShows initiative, confidence, and enthusiasm in collaborative environments, actively promoting and implementing best practicesStrong team player, able to work effectively across functions and build constructive relationshipsCapable of maintaining composure under pressure, with a resilient mindset in fast-paced or challenging situationsExcellent interpersonal and communication skills, with the ability to present confidently in cross-functional and external meetings, ensuring clear and open information flowExperience in root cause analysis and risk management/assessment is highly desirable

 

 

 

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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.