Location: Belgium, Leuven | Job Ref: AXSM004
Overview:
Our client, a fast-growing medical device manufacturer is seeking a Senior Manager – Quality Systems to lead quality improvement initiatives across design, manufacturing, and post-market activities. The company has a strong R&D pipeline in surgical devices and is scaling operations across Europe.
Key Responsibilities:
-
Own and develop the QMS to meet EU MDR, ISO 13485, and FDA 21 CFR Part 820
-
Drive supplier quality oversight and partner with product development
-
Lead document control, QMS training, audits, and management reviews
-
Deliver cross-functional quality and compliance improvement projects
Requirements:
-
7+ years in QA roles within MedTech or diagnostics
-
Proven experience with EU MDR and ISO 13485
-
Fluent in English; French or Dutch is a plus
Why Join?
-
Join a MedTech innovator with a strong European footprint and ambitious growth plans
-
Take ownership of quality systems in a fast-moving, hands-on environment
-
Attractive package including salary, on-site perks, and international exposure
-
Work closely with R&D and commercial teams in a product-focused company
Equal Opportunities Employer
Axion is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
