At Wipro Limited, I investigated medical device complaints while maintaining compliance with FDA and EU MDR requirements. I achieved 98% on-time complaint closure within established regulatory timelines.
I performed complaint evaluation and IMDRF coding, conducted root cause analysis, and supported CAPA activities. I also reviewed service reports, product analysis reports, and Device History Records.
I maintained complaint documentation in TrackWise and used Power BI and Excel to identify complaint trends and develop dashboards for quality metrics. I collaborated with engineering and quality teams on complaint resolution and supported audit preparation and regulatory inspections.
I was recognized multiple times as Best Complaint Evaluator for quality and productivity. I also founded and scaled an NGO to 30+ members serving 100+ beneficiaries monthly.
