Amit Jha
Complaints Specialist @辉瑞
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WORK HISTORY
Complaints Specialist @辉瑞
Collegeville, PA, US
Assessed medical device and combination product complaint narratives to make reportability determinations for US and Rest of World Markets.•Managed weekly team meeting for complaints team of 30+ individuals including 2 directors to communicate updates, best practices, and achievements.•Created complaint file conclusions that included information such as reportability, site investigations,and device engineering investigations.•Served as a subject matter leader for 12+ complaint specialists providing individualized and group coaching for the end-to-end complaint file process.•Team liaison for complaint files with site investigation units and device engineering unit for process improvement projects and systemic issues.•Managed metrics for closing process to provide management insight on overall closing performance.
EDUCATION
Arizona State University
Master's degree, Biomedical Engineering
Arizona State University
Bachelor's degree, Biomedical Engineering
SKILLS
ABOUT AMIT JHA
Quality Industry Professional, Certified Lean Green Belt and Certified Six Sigma Green Belt with over 6 years experience working in quality field with medical device and combination products.Core competencies include: • Six Sigma • Lean • Post Market Surveillance • Design Verification • Quality Risk Management • Root Cause Analysis
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