Santhosh A is a Sustaining Quality Engineer with 8+ years of experience driving validation, quality, and process improvements for electromechanical and IVD medical devices across NPI, sustaining projects, and facility expansions. He has led CQV and CSV activities for new facility builds and technology transfers while ensuring compliance with FDA 21 CFR, ISO 13485, ISO 14971 and related standards. Known for introducing automated systems into manufacturing, he combines mechanical engineering expertise with statistical and project management skills to deliver measurable reliability and safety improvements. Promoted into roles such as OJT and Calibration Coordinator, he mentors operators and embeds continuous improvement and 5S practices on the shop floor. Comfortable working globally, he brings hands-on experience from startups to large medtech firms and an MS in Mechanical Engineering that underpins his technical and validation leadership.
8 years of coding experience
3 years of employment as a software developer
Jawaharlal Nehru Technological University Hyderabad
Master of Science - MS, Mechanical Engineering, Master of Science - MS, Mechanical Engineering at Wright State University
Contributions:10 pushes, 1 branch in 3 years 10 months
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Santhosh A - Sustaining Quality Engineer at Hologic, Inc.