Amala K

Quality & Validation Engineer @Regeneron

NY, US

As a Quality Engineer supporting a U.S-based pharmaceutical and medical device client, I lead end-to-end quality and validation initiatives across advanced manufacturing and regulated environments. My role focuses on ensuring compliance with FDA, ISO 13485, cGMP, and aerospace quality standards while driving continuous improvement and operational excellence.I manage process validation for infusion pumps and automated drug delivery systems, including the development and execution of IQ/OQ/PQ protocols. I have also led validation efforts for CNC machines, document management systems, and precision tooling, ensuring robust performance and regulatory compliance.A key part of my work involves integrating engineering and quality systems—streamlining workflows by connecting CAD and PLM platforms such as Windchill and Teamcenter. I’ve developed engineering design packages for equipment upgrades and collaborated with cross-functional teams and external vendors to align project scope, timelines, and technical requirements.I conducted a comprehensive gap analysis of calibration processes against AS9100 standards, implementing corrective actions that reduced calibration-related non-conformances by 15%. Additionally, I established design controls across the product lifecycle, ensuring full traceability and audit readiness.

Geethanjali College of Engineering and Technology

Bachelors degree