Cepheid
Mike Ornelas is a Senior Director of Quality Systems at Cepheid, where responsibilities include global strategic direction and operational coordination to ensure compliance with FDA, ISO, and other regulatory requirements, along with oversight of quality system processes. Previous roles include Director of Quality Systems and Senior Manager Quality Systems at Cepheid, and Director of Quality Assurance and Compliance at Genomic Health, where development and commercialization of genomic tests were managed. Additional experience encompasses positions as Divisional Director of Quality Systems at Covidien, Quality Systems Manager at Varian Medical Systems, Quality Assurance Manager at Avocet Medical, and Manufacturing Supervisor at Dade Behring. Mike Ornelas holds a Bachelor of Arts in Microbiology from the University of California, Berkeley.
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Cepheid
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Cepheid is a molecular diagnostics company. The Company develops, manufactures and markets fully-integrated systems for testing in the Clinical and Non-Clinical markets. The Company's systems enable molecular testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The Company's systems integrate these steps and analyze biological samples in test cartridges. Its primary offering is the GeneXpert system, which integrates sample preparation in addition to Deoxyribonucleic acid (DNA) amplification and detection. The GeneXpert system is designed for a range of user types ranging from reference laboratories and hospital central laboratories to satellite testing locations, such as emergency departments and intensive care units within hospitals, as well as physician offices and other alternate site laboratories. It also offers the SmartCycler system, which integrates DNA amplification and detection to allow rapid analysis of a sample.