Work as a Quality Control Specialist for a client company in Utrecht, coordinating reagent QC, assessing results and improving processes in line with ISO 13485 and IVDR. PCR and NGS experience is required; 32–40 hours per week.
The role
At a client company in Utrecht, you will work in quality control of reagents for molecular diagnostics. You will evaluate test results against specifications and help maintain and continuously improve QC processes in line with ISO 13485 and IVDR.
Responsibilities
- Plan and coordinate reagent QC with the QC Coordinator.
- Authorize reagent QC checks, quality reports and certificates of analysis (CoAs).
- Maintain and update QC reports, training forms, protocols, specification documents and SOPs.
- Analyze trends in QC data and optimize procedures.
- Implement and coordinate validation of QC procedures for new products.
- Participate in deviation investigations, root cause analyses and CAPA activities.
What you bring
- A BSc or MSc in Life Sciences, Molecular Biology or a related field.
- At least 2 years of QC or laboratory experience in the IVD or biotech sector.
- At least 1 year of experience coordinating quality technicians.
- Hands-on experience with molecular biology techniques and data analysis, particularly PCR-based methods and NGS sequencing.
- Strong attention to detail, documentation and organizational skills.
- Excellent written and spoken English.
- A proactive, solution-oriented approach and a collaborative mindset.
- Familiarity with NCR/CAPA, IVDR and ISO 13485 QMS processes.
- Experience writing or reviewing SOPs or protocols, analyzing data trends or supporting audits is an advantage.
- You live within a reasonable commuting distance of Utrecht or are willing to relocate.
What is offered
- 32–40 hours per week; a 40-hour week is full-time, with 0.8 or 0.9 FTE options available.
- Market-competitive salary.
- Pension plan and commuting allowance.
- Laptop.
- 25 days of annual leave plus one paid week off at Christmas.
- Free sports membership.
- Employee assistance program.
- An international work environment and a team focused on delivering high-quality products.