I am a seasoned freelance Quality Assurance Specialist with extensive experience in ISO 13485, dedicated to enhancing quality management systems, particularly within the medical device industry. My work has focused on essential areas such as CAPA management, non-conformities, audit preparation, and implementing eQMS solutions like ManualMaster and MasterControl. I’ve successfully guided organizations through regulatory transitions from MDD to MDR and optimized supplier onboarding processes to uphold rigorous compliance standards.
As the founder of Kuijper Solutions, I’ve partnered with medical device companies on long-term projects, supporting both contract and legal manufacturers in maintaining regulatory compliance. My background also includes quality assurance roles in the cosmetics and automotive sectors, where I bring a commitment to quality excellence and a proactive approach to managing complex regulatory landscapes.More...