Troy Evangelista

Senior Director, Quality Assurance And Regulatory Affairs at First Light Diagnostics

Troy Evangelista has a diverse work experience in the field of quality assurance and regulatory affairs. Troy is currently serving as the Director of Quality Assurance and Regulatory Affairs at First Light Diagnostics since August 2019. Prior to this, they worked as the Director of Diagnostic Quality Systems at Gritstone Oncology from July 2016 to November 2018. In this role, they were responsible for drafting SOPs and managing the quality system.

Before joining Gritstone Oncology, Troy worked as a QA/RA Compliance Consultant at QA/RA Compliance Consulting from May 2015 to January 2016. Troy also served as the Director of Regulatory Affairs and Quality Assurance at BG Medicine from June 2012 to April 2015. At BG Medicine, they managed the company's quality system and contract manufacturer for the Galectin-3 ELISA Test Kit.

Prior to that, Troy worked as the Senior Quality Assurance Manager at Keystone Dental Inc. from February 2010 to March 2012. Troy was responsible for managing the company's quality system and personnel in QA, PMQA, and Document Control.

Troy started their career at Cytyc Corporation in 1995 as a Quality Assurance Manager. When Cytyc Corporation was acquired by Hologic Incorporation in October 2007, they continued working as the Quality Assurance Manager until September 2009. Troy was responsible for overall management of the Diagnostic Division's quality system and personnel, establishment of quality policies and procedures, and managing compliance projects.

Troy's earliest work experience was as a Process Engineer/Associate QA Engineer at Medisense, Inc. from December 1989 to December 1995. Troy focused on improving product quality, managing supplier quality, and establishing a product refurbishment program.

Overall, Troy Evangelista has a strong background in quality assurance and regulatory affairs with experience in managing quality systems, drafting SOPs, and ensuring compliance with FDA and ISO requirements.

Troy Evangelista began their education journey in 1991 at Northeastern University, where they pursued a Bachelor of Science degree in Mechanical Engineering Technology. Troy successfully completed their undergraduate studies in 1995. Years later, Troy returned to Northeastern University in 2016 to pursue a Master of Science degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices. Troy completed their postgraduate studies in 2018, further enhancing their knowledge and expertise in the field.

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  • Senior Director, Quality Assurance And Regulatory Affairs

    August, 2019 - present

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