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Brian Hardin currently serves as the Senior Manager of Design and Product Lifecycle Quality at QuidelOrtho and as the Senior Manager of Quality Assurance Engineering at Quidel, having been with the company since 2013. With extensive experience in quality management and engineering for medical devices, Brian specializes in ISO 14971:2012, ISO 13485, CAPA, Risk Management, and Design Control within the in-vitro diagnostics sector. Previous roles include Quality Engineer IV at Alere Inc. and Senior QA Engineer at Quidel, along with experience as a Quality Engineer at Sotera Wireless and process engineering positions at Axelgaard Manufacturing, Arlon, and Hewlett Packard. Brian holds a Bachelor of Science in Biochemistry from the University of California, Riverside, and a Six Sigma Green Belt certification from California State University, Fullerton.