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Karolien Janssens is a highly experienced quality systems engineer with a strong background in the medical device and healthcare industry. Currently serving as a Senior Quality System Engineer - Design at Fisher & Paykel Healthcare, Karolien specializes in industrial sterilization and test method validation, ensuring compliance with various ISO standards. The professional journey includes roles as Senior Quality System Engineer - Manufacturing and as a Quality Systems Engineer, focusing on quality assurance and regulatory compliance. Previous experience includes quality compliance coordination at Danone and quality control roles at Aroa Biosurgery and Pfizer. Karolien holds a Clinical Master's degree in Pharmaceutical Sciences from KU Leuven and an Academic Bachelor's degree in Biomedical Sciences from Hasselt University.