Clinical & Digital Devices Quality Lead – Contract Role
Type: Temporary contract – Not working directly for the client
Start: ASAP (ideally 1 April 2026, flexible)
End: End of 2026, with extension into 2027
Location: Belgium or Switzerland preferred. Hybrid for Belgium (2 days onsite). Remote possible for other EU locations (excluding UK & Germany).
Workload: Full‑time only.
Context
The 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 Responsibilities
- Act 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 Have
- Minimum 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 Profile
- Background 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 Have
- Exposure to Computer System Validation (CSV).
- Experience in clinical trials and/or commercial device environments.
- Experience with quality agreements.
- French language skills.
Additional Notes
- Digital 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).