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.
With a highly educated and motivated team of about 100 colleagues, we contribute to the quality of life of transplant patients.
To strengthen our team, we offer a challenging position for a detail-oriented and proactive Quality Assurance Associate with strong organizational and communication skills.
As Quality Assurance Associate at GenDx, you contribute to ensuring compliance with industry regulations, maintaining high-quality standards, and overseeing quality processes. This role will involve working closely with cross-functional teams. Together, we aim to improve patient outcomes by offering the best possible diagnostic tools, balancing innovation and high quality.
Responsibilities
- Document control: Prepare, develop, review and maintain quality documentation, including standard operating procedures (SOPs) and change controls.
- Support with investigating and resolving quality deviations, non-conformities and corrective and preventive actions (CaPAs).
- Support with ensuring that (manufacturing) processes are compliant to quality standards.
- Support with internal and external audits.
- Train employees regarding the QMS.
- Work according to ISO 13485, IVDR and other relevant standards.
Requirements
- BSc degree in molecular biology or a related field.
- 1-3 years of professional working experience.
- Strong affinity with quality, safety surveillance, standards and reports.
- Focused and well-organized workstyle.
- Well-developed communication and organization skills.
- Good at keeping overview with attention to detail.
- Can work both independently and as part of a team.
- Experience with quality management systems (QMS) and document control software is preferred.
- Experience with working in an ISO 13485 and/or IVDR -compliant company is a plus.
- Excellent professional command of English (written and spoken).
- You currently live, or are willing to relocate, in the proximity of 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, based on experience.
- 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 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 by clicking the button below. Please mention ‘2024_19’ and your name in the e-mail subject line.