statistical process control (SPC), calibration of test measuring equipment, inspection test plans, Data Analysis, Risk Assessment, 6-Sigma Black Belt, quality assurance plans, Iso 9001, external audits, Ohsas, Lean Manufacturing, quality metrics, root-cause analysis

risk management, regulatory intelligence monitoring, Iso 14971, Iso 13485, CAPA management, electronic QMS eQMS platforms, non-conformance investigation methodologies, AI-assisted tools, CE-IVD IVDR requirements, HSA Singapore MDA regulations

8d problem solving , QMS - ISO 9001, Sql, Excel, Reliability Engineering, Yield Analysis, Fmea, Defect Reduction, IATF 16949, Jmp, Capa, Minitab, Pfmea