Clinical & Digital Devices Quality Lead – Contract RoleType: Temporary contract – Not working directly for the clientStart: ASAP (ideally 1 April 2026, flexible)End: End of 2026, with extension into 2027Location: Belgium or Switzerland preferred. Hybrid for Belgium (2 days onsite). Remote possible for other EU locations (excluding UK & Germany).Workload: Full‐time only.
ContextThe client is expanding their Device & Digital Quality function due to increasing digital health activities, clinical trial growth and upcoming audits. This global QA role supports both clinical and commercial digital initiatives within a small, highly cross‐functional team (Quality, Clinical, Regulatory, IT, Business). The environment is fast‐moving, with processes still being built, so a pragmatic, hands‐on profile is essential.
Key ResponsibilitiesAct as QA Lead for clinical studies involving medical devices and digital tools.Qualify vendors and digital/medical device solutions (SaMD, computerized systems, web‐based tools).Assess fit‐for‐purpose, compliance and risk for clinical and commercial use.Support commercial digital tools such as web‐based applications.Conduct vendor qualification and quality assessments.Contribute to audit and inspection readiness, especially in digital areas.Help define and improve device/digital quality processes.Communicate complex technical topics clearly to non‐experts across functions.
Must HaveMinimum 3+ years in medical devices, digital health technologies or software‐based systems within life sciences.Strong exposure to digital systems (SaMD, digital tools, computerized systems).Vendor qualification and solution assessment experience.Solid QA/compliance understanding with a hands‐on, practical approach.Experience supporting or preparing for audits (ideally digital).Ability to summarise risks and key messages clearly.Knowledge of at least 2 of the following: ISO 13485, ISO 14155, EU MDR, 21 CFR 820.
Ideal ProfileBackground in biomedical engineering, engineering, life sciences or software.Strong digital mindset with the ability to simplify technical content.Structured, pragmatic and able to prioritise what matters.Comfortable taking ownership in a small, evolving team.Skilled at extracting the "big picture" and communicating clearly.
Nice to HaveExposure to Computer System Validation (CSV).Experience in clinical trials and/or commercial device environments.Experience with quality agreements.French language skills.
Additional NotesDigital experience is more urgent than clinical experience.Senior candidates can be considered if they remain practical and hands‐on.Flexibility around start date for strong profiles (e.g., Swiss notice periods).
Apply NowApply directly or email your CV to: glenn.fairbrother@msipharma.com