Jigar Shah

Senior Manufacturing Quality Engineer @Cepheid

Lodi, CA, US

Lead new product introduction and production line qualification and validation from Quality team.• Lead the Risk assessment activities (pFMEA, dFMEA, pHA) for an existing and new production line.• Build the Quality Control plan and risk management plan for the manufacturing process.• Utilize advanced statistical tools (Cp, Cpk, Control chart) to monitor and evaluate new manufacturing processes.• Lead design validation activities and HFE activities and risk management activities for new product introduction.• Support on-site external ISO13485 Certification Audit and conduct Internal Audits, Layered process audits by Danaher.• Lead the MRB team to support the root cause analysis, disposition of non-conforming products.• Generate, Review & Approve the Validation Master Plan, Qualification protocols and reports.

SVIT, Vasad Official

Bachelor’s Degree, Mechanical Engineering

University of Houston

Masters, Industrial Engineering

Parth School of Science and Competition

High School, science stream

University of Maryland

Master of Engineering - MEng, Robotics Engineering