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Sandhya Krishnamurthy

@sandhyakrishnamurthy

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Senior Quality Assurance specialist focused on medical device compliance.

India

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What I'm looking for

I seek a role where I can lead QMS and regulatory compliance for medical devices, drive audit readiness, improve processes, and collaborate cross-functionally to ensure product safety and quality.

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.

Experience

Work history, roles, and key accomplishments

Current

Senior Quality Assurance Specialist

Current

Inito Health Tech Pvt Ltd

Mar 2020 - Present (5 years 7 months)

Manage QMS documentation and controls, lead audits and CAPA activities, and execute risk management and usability engineering for medical devices, enabling ISO 13485 and 21 CFR Part 820 compliance and successful external audits with zero non-conformities.

ISO 13485 21 CFR 820 ISO 14971 CAPA Vendor Management

Senior QC Associate

Jana Med Tech Pvt Ltd

Aug 2017 - Apr 2019 (1 year 8 months)

Executed quality control across manufacturing stages, led stability study design and analysis, managed raw material inspections and vendor controls, and investigated product complaints to maintain product quality and shelf-life compliance.

Quality Control Trend Analysis Data Analysis