About the Role
We’re seeking a QA Manager to oversee and manage the Production Quality Management System for a leading medical device manufacturer. You will be accountable for ensuring product quality across materials, components, and final goods – from batch release to deviation handling, and compliance with GMP and ISO standards.
As QA Manager, you will lead the QA Production team, work closely with internal and external stakeholders (including suppliers, production, and sales/marketing), and support both day-to-day operations and strategic improvement projects.
Key Responsibilities
* Lead the QA Production team and ensure compliance with GMP, ISO 13485, and internal QMS standards
* Oversee batch release and ensure timely, compliant release of finished products
* Manage deviations, non-conformities, complaints, and CAPAs with focus on root cause and prevention
* Act as primary QA contact for production, suppliers, and key stakeholders
* Drive continuous improvement and support quality training across production teams
* Ensure QA documentation and change controls are properly reviewed and approved
Requirements
* Higher scientific degree (e.g. Pharmacy, Industrial Engineer, Bio-engineer)
* Experience in a GMP-compliant production environment (preferably medical devices, pharma, or life sciences)
* Strong understanding of ISO 13485 and/or 21 CFR Part 820
* Solid experience with QA systems, team leadership, batch release, deviation/CAPA management
* Excellent communication skills and ability to collaborate across departments
* Fluent in Dutch and English
Interested? Let's connect!