Quality Assurance Specialist

Gendx Products Inc.; Utrecht; Hybrid; EUR 55,000 - 85,000; Full time

Benefits offered by this job

International working environment

New office facilities with GenDx café

Commuting traffic compensation

Full-time contract (1.0 FTE)

Part-time option (0.8–0.9 FTE)

Laptop

25 holidays + Christmas leave

Gym membership

OpenUp EAP

Job summary

GenDx is seeking a detail-oriented Quality Assurance Specialist to maintain and develop our Quality Management System in line with ISO 13485 and IVDR. You will collaborate across the organization to ensure product quality, process compliance and continuous improvement.

The role offers a broad, hands-on QA position in a growing molecular diagnostics company near Utrecht Science Park, with opportunities to influence quality culture and regulatory compliance.

Qualifications

• Bachelor’s degree in life sciences (HBO/WO).
• 3–7 years QA experience in a regulated environment (IVD/medical devices).
• Experience with ISO 13485 and/or IVDR.
• Experience with CAPA systems, audits and document control processes.
• Strong affinity with quality systems, risk management and regulatory compliance.
• Excellent English, written and spoken.

Responsibilities

• Prepare, develop, review and maintain quality documentation (SOPs, change controls, records).
• Coordinate investigations related to non-conformities, deviations, complaints and CAPAs.
• Support manufacturing and operational processes compliance with quality standards.
• Assist internal, supplier and external audits.
• Contribute to continuous improvement of the Quality Management System (QMS).
• Train staff on QMS-related processes and procedures.

Skills

QA experience

ISO 13485

IVDR

CAPA/audits

Document control

Regulatory compliance

Risk management

English proficiency

Cross-functional teamwork

Independent worker

Communication skills

Education

Bachelor’s degree in life sciences

Tools

BizzMine

Salesforce

Job description

About GenDx

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 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 120 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 detail-oriented, pragmatic and proactive Quality Assurance Specialist with strong communication and organizational skills.

About the role

As Quality Assurance Specialist at GenDx you contribute to maintaining and further developing our Quality Management System in accordance with ISO 13485, IVDR and other applicable standards. You will collaborate closely with cross-functional teams throughout the organization and play an active role in ensuring product quality, process compliance and continuous improvement activities.

This position offers a broad and hands-on QA role within an innovative and growing molecular diagnostics company. Together, we aim to improve patient outcomes by offering the best possible diagnostic tools while maintaining the highest quality standards.

Responsibilities

• Prepare, develop, review and maintain quality documentation, including SOPs, change controls and quality records.


• Coordinate and support investigations related to non-conformities, deviations, complaints and corrective and preventive actions (CAPAs).


• Support and monitor compliance of manufacturing and operational processes according to applicable quality standards.


• Support internal, supplier and external audits.


• Contribute to continuous improvement of the Quality Management System.


• 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

• Bachelor’s degree (HBO or WO) in molecular biology, biotechnology, biomedical sciences or a related life sciences field.


• 3–7 years of relevant QA experience in a regulated environment (IVD, medical devices, biotech or pharma).


• Experience with ISO 13485 and/or IVDR.


• Experience with CAPA systems, audits and document control processes.


• Strong affinity with quality systems, risk management and regulatory compliance.


• Structured and well-organized working style with strong attention to detail.


• Able to work independently while also functioning effectively within cross-functional teams.


• Strong communication skills with a pragmatic and hands-on mindset.


• Excellent professional command of English, written and spoken.


• Experience with electronic QMS systems such as BizzMine, Salesforce or similar systems is preferred.


• Excellent command of English (written and spoken).


• You currently live near Utrecht Science Park or are willing to relocate within a reasonable commuting distance of the office.


• Please note that you must be legally eligible to live and work in the Netherlands. Unfortunately, visa sponsorship 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 healthy lunch.


• Compensation for commuting traffic.


• Full-time contract (1,0 FTE) based on a 40 hour work week.


• Option to work part-time (0,8 – 0,9 FTE).


• Laptop.


• 25 holidays and a week paid Christmas leave.


• Free membership at sports center Olympos.


• Access to Employee Assistance Program ‘OpenUp’.

Information

For more information you can contact Arnold Catsburg, QA Manager, at [phone].