Marian Kris Canave is a dedicated professional with extensive experience in quality assurance and regulatory compliance within the medical device and diagnostics industries. Currently serving as a Design Assurance Specialist at SEKISUI Diagnostics since May 2022, Marian has previously held roles at Thermo Fisher Scientific, contributing significantly to GMP operations and quality oversight. Experience at International Medication Systems includes the development and maintenance of Design History Files for combination products, risk assessments in compliance with ISO standards, and coordination of design changes. Prior roles in validation engineering cover the development and execution of validation protocols and management of validation documentation. Marian's career began in a medical office setting, where administrative skills were honed before transitioning to the medical device industry. Marian holds a Bachelor of Arts degree in Multi/Interdisciplinary Studies from the University of California, Riverside.
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