QA Auditor - Rotterdam
On-siteRotterdam, South Holland, The Netherlands
Job Summary
Perform study-based audits on validation, analytical plans, raw data, and reports, ensuring findings are accurate and effectively reported. Support regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA, and GAPIV standards. Conduct internal audits, host external audits and regulatory inspections, and review proposed CAPA responses to ensure adequate resolution. Detect deviations, support root cause analysis, and monitor document control processes. Provide ongoing education to staff on quality-related topics and participate in QA-related projects. This 12-month fixed-term role is based in Rotterdam, Netherlands, with a Senior QA Manager providing mentorship.
Required Qualifications
- Bachelor's degree in a relevant scientific field (biology, chemistry, medical technology or related)
- 5+ years' experience in Quality Assurance and laboratory operations
- Strong background in laboratory operations, with an understanding of lab processes and quality control measures
- Experience performing internal audits and supporting external audits or inspections
- Fluent in English
Desired Qualifications
- Dutch and/or French
- Ideally you will have or some experience across ISO17025, ISO15189, ISO13485, ISO9001, GAPIV, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA
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