Quality Manager

QUALITY MANAGER | Nijmegen Area | 32-40 hours a week

We are seeking an experienced Quality Manager to ensure compliance with ISO 13485:2016 and support the ongoing development and improvement of the Quality Management System (QMS) of one of our clients.

Job Summary

You will play a key role in maintaining certification, preparing for MDSAP requirements, managing supplier audits, and ensuring that internal processes are aligned with applicable regulatory standards. You will join a local team of approximately 10 professionals and collaborate closely with a global team of around 40 colleagues. You will report locally to the site manager and functionally to the global HR lead.

This is a unique opportunity to contribute directly to the safety, compliance, and success of an innovative medical device product. You’ll have the autonomy to drive improvements while working in a collaborative, hybrid environment with local and international colleagues. This position is ideal for a hands-on quality professional with strong regulatory expertise in medical devices.

Main tasks

• Ensure compliance of the QMS with ISO 13485, MDSAP, and applicable regulatory/legal requirements.
• Monitor and evaluate vendor quality systems, and manage supplier audits (4 critical suppliers).
• Maintain, document, and improve QMS processes, including writing and updating procedures, templates, and work instructions.
• Lead internal quality reviews, risk assessments (ISO 14971:2019), and gap analyses for MDSAP readiness.
• Report on QMS effectiveness and propose improvements to both local and global management.
• Promote regulatory awareness and quality principles across the organization.
• Provide quality-related training to staff.

Company Details

We are Akkodis. We put the talents, skills and ambitions of our consultants first! Because you continuously offer challenging projects, you will develop quickly and you can realize your ambitions. Akkodis Life Sciences offers internal and external projects in the field of QA, QC, PV, RA, R&D and Supply Chain. Currently, more than 60 consultants work at the EMA, Astellas, GSK, Unilever, Corbion, MSD, Organon, Aspen and many more!

Candidate Profile

Qualifications

• (Master's) degree in Science or Engineering.
• Fluency in Dutch and English.
• At least a couple of years experience in quality management within the medical device, pharmaceutical, or biotech industries.
• In-depth knowledge of ISO 13485:2016 and ISO 14971:2019; experience with MDSAP is strongly preferred.
• Experience with class IIa or higher medical devices.
• Skilled in QMS auditing, document control, and supplier quality management.
• Confident communicator, capable of explaining quality concepts to both technical and non-technical stakeholders.

Are you interested in this challenge, or do you want to come in touch?

Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV and motivation letter.

Benefits

What do we offer?

• Work for 40 hours a week and the opportunity to work at innovative and progressive companies. You will be part of a fast-growing Life Sciences team that is represented in various sectors (biotechnology, pharmaceuticals, food) and is present in Life Sciences clusters in the Netherlands.
• Attractive salary based on experience and education.
• Work-life balance with 24 to 36 vacation days.
• Company fitness, health insurance and a good pension scheme.
• Opportunities for training, coaching and a personal development program.
• Career opportunities that match your ambitions and development.