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. Since 2022, GenDx is part of the Eurobio Scientific Group, headquartered in Les Ulis, France.

With a highly educated and motivated team of about 115 colleagues, we contribute to the quality of life of transplant patients. Do you want to be part of an innovative company that offers ample time for development? To strengthen our team, we offer a challenging position for a Quality Assurance Engineer to deliver reliable diagnostic software that improves the quality of life for transplant patients worldwide.

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As Quality Assurance Engineer at GenDx, you are a key member of our QA Software and Software development team. You are passionate about quality, testing and regulatory documentation. In this role, you will combine genetic or molecular biology knowledge with software QA expertise to ensure our medical software products meet the highest standards of quality, compliance, and reliability. You enjoy being part of cross-functional teams to clarify requirements and ensure thorough verification and validation of our software. In addition, with your coordination skills, you ensure smooth testing of software release candidates and take responsibility for creating, maintaining, and coordinating quality records, such as the Device Master Record in compliance with IEC 62304, ISO 13485, IVDR, and other relevant standards.

Responsibilities

• Create, coordinate and maintain software release documentation and software testing activities.
• Monitor test coverage for existing and new software requirements.
• Collaborate with cross-functional teams to refine software requirements for effective testing.
• Develop, execute, and maintain manual tests.
• Report test results and bugs to the software development team
• Maintain traceability between software requirements, test cases, and verification results.
• Execute validation and verification activities for supporting software and software manufacturing processes.
• Support quality investigations (e.g. deviations, root cause analysis, CAPAs) and continuous process improvement.
• Working according to ISO13485, IEC62304 and IVDR standards.

Requirements

• HBO or BSc degree in Biomedical Engineering, Molecular Biology, Life Sciences, or related field.
• At least 1 year of experience in software testing and/or quality assurance, ideally within a regulated medical or biotech environment.
• Experience in preparing and maintaining quality documentation, especially DMR or similar controlled documents.
• Familiarity with the software development lifecycle, including the use of test management and issue tracking tools (such as SpiraPlan).
• Strong attention to detail, problem-solving skills, and a structured approach to testing and documentation.
• Experience in regulated software and molecular diagnostics is a big plus (e.g. IEC 62304, ISO 13485, NGS, HLA typing).
• Excellent written and spoken English communication skills.
• Based within, or willing to relocate to, a commutable distance from 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.
• Full-time employment contract, based on a 40 hour work week.
• Option to work part-time (0.8FTE minimum).
• Employee Assistance Program (OpenUp).
• Laptop.
• 25 holidays and a week paid Christmas leave.
• Sport pass for Sports Center Olympos.

Information
For more information, you can contact Walinka van Tol at +31 (0)30 252 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 via the button below and maybe you will soon be part of the GenDx team.

Please note: Due to summer holidays, we will start reviewing applications from August 11 onwards. You can expect to hear from us by August 15 at the latest. Thank you for your patience!

If you would like to apply at GenDx, we kindly ask you to contact our HR team directly, via the ‘apply now’ button above. 

To be considered for this position, you must be legally permitted to live and work in the Netherlands.

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Recruitment Privacy Policy.

GenDx does not consider unsolicited resumes from any third-party recruiters/agencies.