Soundar Palanisamy

About Soundar Palanisamy

Experienced Quality and Regulatory professional with over 8 years in the medical device industry, specializing in Software validation, Computer System Validation (CSV), hardware validation, and comprehensive quality management of software and hardware products. Proven expertise in implementing and maintaining compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, EU IVDR, EU MDR, Lab process and AERB standards. Skilled in defect prevention, root cause analysis, CAPA management, Technical document, GSPR checklist PER Tool-Kit preparation as per EU IVDR 2017/746 and EU MDR 2027/745 and risk mitigation to ensure product safety and effectiveness. Adept at coordinating cross-functional teams and driving continuous improvement initiatives that align with regulatory requirements and business objectives. Strong background in supporting internal/external audits and regulatory submissions, with excellent documentation and communication skills.

Experience

1. Design Quality Engineer

   Philips

   Feb 2026 — Present

   I played a pivotal role in ensuring the quality and compliance of medical devices. My responsibilities included managing the quality management system and leading risk management initiatives. I focused on the CAPA process to address quality issues and implemented strategies to prevent defects, contributing to the overall safety, effective and reliability of our products.

Education

• Vel Tech Multi Tech Dr. Rangarajan Dr. Sakunthala Engineering College

  B.E, Biomedical/Medical Engineering

  2013 — 2017