Sandhya Krishnamurthy

I am a Senior Quality Assurance specialist with extensive experience managing QMS, regulatory compliance, and quality processes for medical devices. I have led ISO 13485 and 21 CFR Part 820 activities, run audits, created SOPs, managed CAPAs, and maintained design verification/validation and risk management per IEC 62304 and ISO 14971.

I collaborate across functions to mitigate product and process risks, manage vendor and product control, and support clinical validation and usability engineering per IEC 62366-1. I have a proven track record of successful external ISO 13485 audits with no non-conformities and strong leadership in QMS implementation and continuous improvement.