GenDx, experts in transplant diagnostics
GenDx is a global leader in molecular diagnostic laboratory solutions for high resolution tissue typing of both donors and patients and monitoring transplant success. We combine our cutting-edge software solutions, reagents for DNA sequencing-based HLA typing and Chimerism monitoring strategies with our excellent customer support including a comprehensive education program. Our products are sold all over the world through direct sales and distributors. The GenDx office is based at Utrecht Science Park in The Netherlands, and we have an office in Chicago, IL, USA. Since 2022, GenDx is 100% owned by French entity Eurobio Scientific SA.
At GenDx, a highly educated and motivated team of about 110 colleagues works together to improve the quality of life for transplant patients. Do you want to join an innovative company that offers dynamic and diverse tasks, alongside ample opportunities for development? To strengthen our team, we are offering a challenging position for a proactive and detail-oriented Quality Assurance Manager to lead the QA team in ensuring compliance with ISO 13485 standards and maintaining the highest quality standards across operations .
As Quality Assurance Manager at GenDx , you will oversee the Quality Management System (QMS), including document management and internal audits, while collaborating closely with the Regulatory Affairs (RA) team to ensure alignment with regulatory requirements. The Quality Assurance Manager role is crucial to ensure that our molecular diagnostic reagents and software are manufactured according to all applicable quality and safety standards.
Responsibilities
- Monitoring and ensuring compliance of the quality management system for manufacturing of our high-quality products and services in collaboration with teams from various disciplines.
- Ownership of the process risk management process.
- Perform both internal and supplier audits.
- Host and coordinate external audits from notified bodies together with regulatory affairs.
- Ensure effective implementation of QMS processes, including document control, CAPA, non-conformance management, and process change control.
- Working according to IVD-R, ISO 13485, MDSAP and IEC 62304 standards.
Requirements
- Minimum 5 years of professional experience in a similar role.
- Solid understanding of ISO 13485 standards.
- Experience with IVD-R and/or MDSAP and/or IEC 62304 is a strong advantage.
- Auditor certification is a plus.
- Proven leadership skills, with experience managing and mentoring teams.
- Excellent analytical, critical thinking, and interpersonal skills.
- Strong organizational and problem-solving abilities, with attention to detail.
- Fluency in English (written and spoken).
- Living near or willing to relocate within a reasonable commuting distance to Utrecht Science Park.
What do we offer
- A team of like-minded people who all strive to deliver the highest quality products possible.
- An international working environment.
- New office facilities accommodating the GenDx café to enjoy your daily healthy lunch.
- Competitive salary.
- Pension scheme.
- Compensation for commuting traffic.
- Employment based on a 40 hour work week.
- Laptop.
- 25 holidays and a week paid Christmas leave.
- Sport pass for Sports Center Olympos.
- Option to work part-time (minimum 80%).
Information
For more information you can contact Erica Kremer, PhD, Director Program Management & Compliance, at 030 252 37 99.
Do we match?
Join the experts in transplant diagnostics! Do you want to be part of an innovative company that offers excellent working conditions and ample time for personal development? Apply now and maybe you will soon be part of the GenDx team.
Send your CV and motivation to our HR Team, recruitment@gendx.com .
Please mention ‘2026_06_QAM’ and your name in the e-mail subject line.