Migdaliz M Lipinski

Capa • Quality System • Fda • Iso 13485 • Medical Devices • Regulatory Affairs • Change Control • 21 Cfr Part 11 • Root Cause Analysis • Quality Assurance • Management • Business Process Improvement • Gmp • Process Improvement • Supplier Quality • Iso 14971 • Engineering • Quality Auditing • 21 Cfr • Investigation • Regulatory Requirements • Dmaic • Configuration Management • Six Sigma • Kpis • Resources Management • Risk Management • Quality Management • Program Management • Standard Operating Procedure • Program Development • Change Management • Project Planning • Kaizen • Cross Functional Team Leadership • Decision Making • Problem Solving • Sop Development • Oracle Agile Plm • Non Conforming • Gap Analysis • Trackwise • Complaint Management • Supplier Quality Management • Scar • Project Design • Train the Trainer • Software Quality Management • Regulatory Audits • Pmo Services • Document Management • Quality Systems • Iso9001 Auditor • Quality Control • Gts • Sap Erp • Change Orders • Fmea • Design Control • Continuous Improvement • Engineering Change Management • Cgmp Practices • Agile Testing • Medical Device Directive • Supplier Evaluation • Supplier Performance • Supplier Risk Management • Gxp • U.s. Food and Drug Administration

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