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Sylvie Sion
Lead Auditor and Product Reviewer Medical Devices @Gmed North America
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WORK HISTORY
Lead Auditor and Product Reviewer Medical Devices @Gmed North America
ISO 13485 QMS Audit\\\\nCE Marking for Medical Devices (MDD / MDR - European Regulation)\\\\nMDSAP audit\\\\nISO 13485 CMDCAS (Canada)\\\\nIEC 60601 (electrical safety and EMC), IEC 62304 (Software Lifecycle)\\\\nISO 14971 Risk Management
EDUCATION
BSI
ISO 13485:2016
HEI - Hautes Etudes d'Ingénieur
Engineer
FDA / Health Canada
MDSAP - Medical Device Single Audit Program
BSI
ISO9001:2015 & ISO14001:2015
LNE/GMED
Medical Devices: Electrical Safety IEC 60601 + EMC, Software lifecycle processes ISO62304
Health Canada
CMDCAS - Canadian Medical Device Regulation
LNE/GMED
Medical Device Directive - CE Marking - Technical File - Risk Management
LNE/GMED
Medical devices: BioCompatibility, Cleaning & Sterilization Standards.
ABOUT SYLVIE SION
Today- Senior QA Consultant and Operation Manager at SYMA Consulting - Lead Auditor at GMED: Medical devices ISO 13485:2016, MDD/MDR (CE Marking), MDSAP - Medical Device Single Audit Program, ISO9001:2015- ISO 13485 / MDSAP Instructor at BSI: Lead and Internal Auditor Trainings Past - ISO 9001 Auditor at DQS-UL Mexico - Emergo Group Medical Device Quality Management System Consultant - Compliance Leader at GE Healthcare - Supplier Quality Leader at GE Healthcare - Supplier Quality Engineer at General Motors Specialties: Quality Assurance ISO 13485:2016 ISO 9001:2015 Medical Devices regulations - CE Marking, MDSAP. Process Validation (IQ, OQ, PQ) Electrical Safety ISO TS 16949 Supplier Quality Management Supplier Auditing and Qualification
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