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
1. Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
2. Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
3. Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies
4. Review and approve UCB documentation. Ensure Design History File (DHF) is in place
5. Ensure deliverables are issued in accordance with the D&D plan
Vendor quality management
6. Accommodate design & technology transfer and ensure systems alignment between vendor and UCB
7. Performing focused assessments/audits
8. Preparation and negotiation of Quality Agreements
9. Ensure systems alignment between vendor and UCB
10. Support risk register for the vendor, and follow up on mitigation activities
11. Oversee inspection plans at CMO and UCB
Quality processes
12. Facilitate investigations and resolution of issues relating to deviation and change management
13. Review and approve deviations
14. Track CAPA events and closure
15. Oversee/track change controls
16. Act as the Operational QA link between selected external vendors within the Medical Device and primary packaging portfolio
17. Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
General GMP
18. Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
19. Drive/Support projects related to quality system improvement
20. Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices, Combination Products and primary packaging activities
21. Maintain 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
22. A bachelor’s or master’s degree in a relevant scientific discipline is required
23. A minimum of 3 years’ experience in the Medical Devices sector, ideally in quality assurance
24. Fluency in English (oral and written) is essential; French is a strong asset
25. Demonstrates accountability in decision-making and follow-through
26. Shows initiative, confidence, and enthusiasm in collaborative environments, actively promoting and implementing best practices
27. Strong team player, able to work effectively across functions and build constructive relationships
28. Capable of maintaining composure under pressure, with a resilient mindset in fast-paced or challenging situations
29. Excellent interpersonal and communication skills, with the ability to present confidently in cross-functional and external meetings, ensuring clear and open information flow
30. Experience 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!