Device Development Quality Lead

Make your mark for patientsTo 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, BelgiumAbout the roleThis 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 withThis 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 assuranceOversee 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 planVendor quality managementAccommodate 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 UCBQuality processesFacilitate 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 closureGeneral GMPMaintain 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 commitmentsInterested? For this position you’ll need the following education, experience and skillsA bachelor’s or master’s degree in a relevant scientific discipline is requiredA minimum of 3 years’ experience in the Medical Devices sector, ideally in quality assuranceFluency 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 desirableAre 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