Kumail Naqvi
Senior Quality Engineer @Cytek Biosciences
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WORK HISTORY
Senior Quality Engineer @Cytek Biosciences
EDUCATION
NED University of Engineering and Technology
BS, Mechanical Engineering
ABOUT KUMAIL NAQVI
Detailed oriented individual with over 11 years of hands-on quality engineering experience. Possess extensive knowledge of ISO and FDA compliance requirements. Provide support to manufacturing for adherence to the Quality Management System. Leading cross-functional teams in various projects to ensure effective and timely execution. CORE COMPETENCIES • ISO Lead Auditor: 13485, 9001, 14001 • FDA 21 CFR 820 & 21 CFR 11 • ISO 14971 Risk Management • Design Control • Six Sigma Green Belt • Kaizen, 5S and Gemba • Process Validation – IQ, OQ, PQ • Software Validation IEC-62344 • Customer Interface for NPI • Problem solving using 8D analysis • CAPA, NCMR, SCAR, ECO and MRB • FAI, Gage R&R, DFMEA and PFMEA • Supplier Management and PPAP • Sterilization of Medical Devices • SPC using Minitab • IQMS, SmartSolve, MasterControl, Propel Salesforce & NetSuite • MS Office: Word, Excel, PowerPoint & Visio
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