Sr. Manager Quality Assurance (Medical Device)
CurrentAccomplished Quality Management Professional, skilled in designing and implementing comprehensive Quality Management Systems (QMS) that ensure compliance with ISO 13485:2016 and FDA 21 CFR 820 and 803 regulations, showcasing a proven track record of excellence.Key Skills:• Standard: ISO 13485:2016, FDA Title 21 CFR 820 & 803, ISO 9001:2015, ISO 14971 ISO 19011:2018, ISO 14001:2015, GDP, GMP, Regulatory Affairs• Leadership: Servant Leadership, Regulatory Affairs, Cross-functional Team Leadership, Process Improvement, Strategic Planning, Quality Control and Management, Engineering Management, Change Management• Quality management: Process mapping, FMEA, RCA, Six-Sigma, TQM, Audit, Benchmarking, Kaizen, Balanced Scorecard, Hoshin Kanri, CAPA, Internal Audit, Customer complaint handling, Supplier Qualifications, Product Recall, Training, Non-conformance, Verification and Validation (V&V), Software Quality, Design Assurance and Control, Risk Management, 8D, Fishbone, A3 problem solving, TQM (total quality management), Enterprise Quality Planning, PDCA, DPPM, CTQ, CAPA, DFMEA, PFMEA, PA, CA, Statistical Process Control (SPC), NPI, Quality dashboard, gap analysis, IPQC, AQL, DFSS, GDP, GMP, OBA, VOC, U.S. Food and Drug Administration (FDA)• Lean Manufacturing: 5s, 8 waste reduction, Poke Yoke, Value stream mapping, Kaizen, Six Sigma, MOST, GEMBA, Agile, Process Control, KPI Implementation• Safety: OSHA and customer-recommended safety and ergonomic compliance, U.S. Food and Drug Administration (FDA)• Statistical: Minitab, MS Excel (charts, table, and statistical functions), SPC, PHstat2, ASAP, QI Macros, Design of Experiment (DOE), Pareto charts, Scatter diagrams, and Box plots • Manufacturing: SOP and BOM, AutoCAD, Smart Drawing, SolidWorks, Pro-model Simulation, KPI reporting, Change Management
