Karen is an experienced and results driven professional with 15 years in the ISO 9001 and ISO 13485 regulated IVD/medical device industry. Her expertise spans quality control management/leadership, manufacturing, R&D, validation and product/method transfer. Karen has been involved in many successful in-depth internal and external audits and collaborated with cross-functional teams to investigate and resolve complaints.
Karen educational background includes an MSc in Immunology and Allergy. She also hold certifications in biosafety awareness and in management development.
Karen career thus far reflects a commitment to optimising quality processes, driving improvements and ensuring quality/regulatory compliance in the pursuit of quality excellence.