Exceptional experience leading teams within global Complaint Handling and Product Support, delivering results and exceeding expectations. Creative and motivated leader adept at utilizing exceptional design and planning strengths to accomplish complex projects.
As Quality Supervisor for Complaint Handling at Abbott Diabetes Care, I lead global postmarket surveillance and complaint handling operations across teams in Manila, Kolkata, and Alameda—overseeing more than 250 employees. I manage both the Evaluation and Closure teams, ensuring timely and compliant resolution of complaints in accordance with FDA Medical Device Reporting (21 CFR Part 803), including 5- and 30-day reporting requirements for Potential Reportable Events (PREs).
I have reduced customer complaints by identifying root causes of quality issues and driving continuous improvement initiatives that enhance complaint evaluation and closure efficiency. My leadership has improved cross-functional communication, reduced cycle times, and strengthened the overall effectiveness of complaint resolution processes.
During a critical reorganization, I served as Interim Supervisor of the Medical Events Group, where I personally led the hiring and onboarding of 7 Medical Event Specialists while continuing to oversee the Complaint Handling Group. I ensured uninterrupted regulatory compliance and team performance during this transitional period.
I’ve made significant continuous improvement impacts to complaint handling procedures—streamlining workflows, enhancing clarity, and reducing customer service follow-ups between the Evaluation and Global Customer Service teams. These efforts have improved operational alignment and reduced friction across departments.
In this dual-capacity role, I managed adverse event reporting to regulatory bodies in over 64 countries, each with unique compliance timelines. I integrated risk management into complaint handling and CAPA processes, ensuring global alignment with FDA and international standards. I also led cross-functional collaboration with Quality, Regulatory Affairs, and R&D to revise and optimize complaint handling procedures.
I oversee departmental operations by coordinating personnel, managing non-conformance records, and delivering actionable metrics to senior leadership. By trending complaint data, monitoring quality KPIs, and executing CAPAs, I drive risk mitigation and support divisional goals. My leadership ensures a robust quality system that prioritizes patient safety and product reliability.