Quality Assurance Associate

GenDX Products Inc.; Utrecht; On-site; EUR 48,000 - 62,000; Full time

Benefits offered by this job

International environment

40 hour work week

Part-time option

GenDx café lunch

Commuting allowance

Laptop

Employee Assistance Program

Job summary

GenDx, headquartered in Utrecht, is seeking a detail-oriented Quality Assurance Associate to maintain our Quality Management System and ensure products meet quality requirements. You will collaborate across departments and support a broad range of QA activities.

This hands-on role offers opportunities to grow QA knowledge in a growing molecular diagnostics company, with training, audits, and exposure to ISO 13485, IVDR, CAPA, and regulatory compliance.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• 1–3 years in regulated life sciences environment preferred.
• Strong quality systems and regulatory awareness.
• Familiarity with ISO 13485, IVDR, QMS or audits preferred.
• Excellent English skills, both written and spoken.
• Eligible to work in the Netherlands.

Responsibilities

• Maintain and update the Quality Management System documentation.
• Review non-conformities, deviations, CAPAs and QA approvals.
• Monitor manufacturing and operational process compliance.
• Support document control and other QMS activities.
• Assist internal and external audits.
• Train staff on QMS processes.
• Support risk management activities and QA projects.
• Work according to ISO 13485, IVDR and applicable standards.

Skills

Quality Assurance

Documentation

CAPA

Regulatory compliance

Education

Bachelor's degree in life sciences

Tools

ISO 13485 familiarity

IVDR knowledge

Audits experience

Job description

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 Associatewith 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.

Responsibilities

• 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.

Requirements

• 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.
• 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 [phone].

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.