Sonja is an expert of Biocompatibility and is part of Qserve's Quality Assurance Team. She is very experienced in setting up ISO 13485 quality systems and technical files, performing internal and supplier audits, translating processes in flowcharts and has a hands-on mentality and practical approach.
The Biomaterials department formed several spin-off companies and Sonja worked within these companies as Study Director Biological Safety Testing and as freelance Project Manager for research in Biomedical product development (Polymers and Bioceramics). After years of practical experience, Sonja joined a Dutch Notified Body as Project Manager, Lead Auditor, and Technical File reviewer.
Sonja started working with Quality systems and Regulatory Affairs in 1997 and has experienced both fields from multiple perspectives. Her portfolio of clients is broad and, among other projects, she is currently involved in a European Reseach project developing a nerve guide conduit. Sonja successfully completed the NAMSA training “Regulatory Toxicology of Medical Devices: An Advanced Course”.
Sonja has a Bachelor degree in histo-, cyto, and pathology. She went on to further her professional career at the University of Leiden, Dept. Biomaterials, as a Research Technician in developing biodegradable bone implants.
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