SEKISUI Diagnostics
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.
This person is not in any offices
SEKISUI Diagnostics
4 followers
Headquartered in Burlington, MA, for 40 years SEKISUI Diagnostics has been committed to helping improve the lives of patients by providing innovative medical diagnostics to physicians and laboratories. We continue to invest in the areas of diabetes, infectious disease, coagulation, diagnostic enzymes and automated systems, and have a leading position as a provider of rapid tests in the US and high throughput coagulation systems in Japan. Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan, making us a worldwide company with R&D and Manufacturing facilities on three continents. We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include: • Clinical chemistry reagents • Coagulation reagents • Point-of-care rapid tests and immunoassay system • Enzymes and specialty biochemicals