Somesh Lalithraj is currently Vice President, Global Quality with Cepheid Inc (a Danaher Company), and responsible for end to product lifecycle Quality including New Product Development, Quality System, Operations Quality and Post Market Quality. He is responsible for manufacturing and distribution sites worldwide including the United States, Europe, Latin America and Asia.
He has 20 years of experience within the regulated medical device space, mainly focusing on reliability and quality assurance activities. He has extensive experience with comprehensive quality planning and process implementation, manufacturability, design for reliability, vendor/contract manufacturer quality, production process control, failure investigation/root cause analysis and CAPA-related activities. Somesh is also a passionate advocate of continuous improvement and is a certified Lean practitioner.
He has interacted with numerous governmental and non-governmental regulatory bodies/agencies and has helped organizations resolve FDA warning letters and NB findings.