Technician Laboratory Equipment

GenDx >

Prepare, review and maintain quality documentation, including SOPs, change controls and quality records. Handle and review non-conformities, deviations, complaints and corrective and preventive actions (CAPAs), including QA review and approval where applicable. Monitor compliance of manufacturing and operational processes with applicable quality requirements. Support document control and other Quality Management System activities. Support internal, supplier and external audits. Train and support employees regarding QMS-related processes and procedures. Support risk management activities and quality-related projects. Work according to ISO 13485, IVDR and other relevant standards and regulations.

Education: Bachelor’s degree (HBO/BSc) in molecular biology, biotechnology, biomedical sciences or a related life sciences field. Experience: 1–3 years of relevant work experience in life sciences, preferably in a regulated environment such as IVD, medical devices, biotech or pharma. Affinity with quality systems and regulatory compliance. Knowledge of or experience with ISO 13485, IVDR, QMS, CAPA and/or audits is preferred. Structured and well-organized working style with strong attention to detail. Able to work independently while also working effectively as part of a team. Strong communication skills with a pragmatic and proactive mindset. Excellent professional command of English, written and spoken. To be considered for this position, you must be legally permitted to live and work in the Netherlands. Sponsorship for a work visa may not always be possible. 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, freshly prepared lunch. Pension scheme. 25 holidays and a week paid Christmas leave. Compensation for commuting traffic. Full-time contract of 40 hours/week (1.0 FTE). Option to work part-time (0.8 FTE minimum). Sport pass for Sports Center Olympos. Employee Assistance Program (OpenUp). Laptop. Information For more information you can contact Arnold Catsburg, QA Manager, 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? via the button below, and maybe you will soon be part of the GenDx team. 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. We will take all steps reasonably necessary to ensure that your data is treated securely, and confidentially, in accordance with the GenDx Recruitment Privacy Policy . GenDx does not consider unsolicited resumes from any third-party recruiters/agencies.

> Careers > Quality Assurance Associate GenDx is hiring: Quality Assurance Associate GenDx, where innovation drives 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 transplant surveillance 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 headquartered 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 motivated and educated team of over 200 colleagues, we contribute to the quality of life and survival chances 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 detail-oriented, proactive and quality-minded Quality Assurance Associate with strong organizational and communication skills. As Quality Assurance Associate at GenDx you contribute to maintaining our Quality Management System and ensuring that our products and processes meet applicable quality requirements. You will work closely with colleagues from different departments and support a broad range of QA activities. This position offers a broad and hands-on QA role within an innovative and growing molecular diagnostics company, with plenty of opportunities to further develop your QA knowledge and experience.