Sanjay Srinivasan

About Sanjay Srinivasan

A seasoned, unconventional, multilevel-thinking Quality Leader with a unique blend of qualifications that includes a Certified Six Sigma Black Belt, Certified ISO 9001:2015, and Certified ISO 13485:2016 Lead Auditor with a Master of Science in Industrial Engineering Management and a Bachelor in Mechanical Engineering.Boosting over thirteen(13) years of experience in various facets of Quality Management, including Design Quality, Sustaining, Cost Saving, Post-Merger Quality System Integration, Remediation, Biocompatibility, and Sterilization.I have spearheaded a multitude of disruptive innovations and projects, such as:Successfully led post-merger DHF transfer, Quality System integration, and other sustaining operations.Successfully led Manufacturing Line Transfer/Extension Projects to Mexico, Dominican Republic, Costa Rica, and China as part of cost-saving projects. Expert in Crisis Management led various Unplanned Events like power outages in Costa Rica’s manufacturing facility, Post Acquisition Product Launch activity, and FDA’s Unannounced Audits.Successfully led Acquisitions and Merger projects as part of the organization’s portfolio expansion.Successfully led a multitude of supplier qualifications and audits.Led ISO 13485 Surveillance and FDA Audit Readiness program. Expert in Biocompatibility Evaluation for Medical Devices.Study director for overall Sterilization(Ethylene Oxide/Radiation) Validation and Annual Re-qualification for Medical Devices.Successfully led verification and validation activities related to disruptive innovations in medical device new product development. Expertise in EU MDR(European Union Medical Device Reporting). Extensive knowledge of ISO 13485, 21 CFR 820, ISO 14971, IEC 62366, ISO 15223, ISO 10993, ISO ISO 60601, and several others.Authored and maintained Risk Assessment Document (pFMECA, dFMECA) and Risk Analysis.Expertise in Statistical Process Control, including tools like Minitab.Expertise in leading CAPA and NCRs.Expertise in Test Method Validations. Expertise in Process Validation and Design of Experiments. Supported various internal & external audit programs ranging from Medical Device Single Audit Program (MDSAP), FDA, ISO 13486, ISO 9001, etc. successfully.

Experience

1. Quality Engineer

   Intuitive

   Oct 2025 — Present · Sunnyvale, CA, US

Education

• New Jersey Institute of Technology

  Master of Science - MS, Engineering/Industrial Management

• Bangalore Institute of Technology

  Bachelor of Engineering - BE, Mechanical Engineering