Lei Li

Lei Li has a diverse and extensive work experience in the field of quality assurance and regulatory compliance. They have most recently held the role of Associate Director of Audits at GRAIL, Inc. since February 2021. Prior to that, Lei Li served as the Quality System Manager at Vyaire Medical from February 2018 to February 2021. They also have experience at Masimo as an Internal Audits Manager, where they managed internal audit programs, maintained compliance with regulations/standards, implemented MDSAP, and provided support for external audits such as supplier, ISO, and FDA audits. Lei Li also worked as an Internal Auditor at Masimo from July 2015 to October 2016. Additionally, they served as a Quality Assurance/Regulatory Specialist at Syneron Candela, where they acted as the Management Representative for a domestic facility and facilitated regulatory and quality functions in North America. Lei Li's earlier experience includes working as a Quality Assurance Supervisor at WaveSense.

Lei Li obtained a Bachelor's degree in Genetics from the University of California, Davis from 2003 to 2005. Lei Li is currently pursuing a Master of Business Administration (MBA) degree from the University of Illinois Urbana-Champaign, which is expected to be completed in 2023. Additionally, Lei Li has obtained several certifications including ASQ Certified Quality Engineer from ASQ - World Headquarters in February 2019, ISO 13485 Lead Auditor from Exemplar Global, Inc. in June 2017, and ASQ Certified Quality Auditor from ASQ - World Headquarters in December 2013. There are also certifications in EU IVDR Auditor, ISO 13485 Internal Auditor, and Regulatory Affairs Certification, but the specific months and years of obtaining these certifications are not provided.