QA Associate, Molecular Diagnostics & Regulatory Compliance

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, 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.