QA Specialist | ISO 13485, IVDR & CAPA

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

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.