vishvant07

Having 10 Years of Experience as a Technical Lead in Medical device industry Having deep knowledge of End to End process of USFDA Complaint Handling Unit (CHU) – Corrective Action and Preventive Action (CAPA), Closure of Non- Conformity (NC), Root cause Analysis (5WHY, Fishbone Diagram, Tree concept etc.), Lean Six Sigma, Technical Investigation Having Knowledge of 21CFR820, 510(K) application, Project Management Experienced in quality engineering disciplines and improvement tools, such as: Root cause analysis, corrective action, standard improvement processes, statistical methods, lean manufacturing, etc. Knowledge of Quality Management System modules such as Quality Incidents, Deviation, APQP, SPC, Investigation, CAPA, and Change Management in eQMS applications (Track wise). Working knowledge of Quality Tools (Process Mapping, Risk Analysis, Cause & Effect Diagrams, Pareto Analysis, etc.) Software Knowledge: Track wise, Super, MS office.