Manish Shah

Manish Shah is a seasoned professional with extensive experience in quality engineering and process management. Currently serving as a Staff Quality Engineer at Johnson & Johnson since March 2021, Manish previously held roles at Advanced Sterilization Products as a QARI Supervisor and Staff Quality Engineer, and at Tata Consultancy Services as a Process Engineer. With a solid foundation in quality systems, Manish has successfully maintained compliance with FDA QSR, ISO-13485, and IVDD regulations, hosted audits, and evaluated post-market incidents. Manish has also worked in various capacities related to validation and quality assurance at Herbalife, Helix Medical LLC, Agilent/HYCOR Biomedical, and FHP, contributing to significant process improvements and quality management initiatives. Manish holds a BSc in Organic Chemistry and a Bachelor of Science in Chemistry from Gujarat University.