Usha
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Quality Engineer and Post-Market Surveillance professional with 5+ years of experience in the medical device and pharmaceutical industries, specializing in complaint investigations, Supplier qualification, supplier audits, risk assessment, and regulatory compliance. Proven track record of analyzing 1,000+ product complaints, including high-risk events, and authoring FDA MDRs while ensuring strict adherence to timelines and quality standards. Strong expertise in CAPA, NCR management, root cause analysis, and validation activities (IQ/OQ/PQ, TMV) within ISO 13485 and cGMP environments. Experienced in supplier quality management, audits, and continuous improvement initiatives across global operations. Proficient in TrackWise, SAP, SFDC, and Power BI to drive data-driven insights and improve product quality, with a collaborative approach to strengthening quality systems, ensuring audit readiness, and delivering compliant outcomes.
M.S. – Health Informatics & Analytics, UNC Charlotte, NC