sylvie sion

lead auditor medical devices iso13485

About

Today: - Senior QA Consultant and Operation Manager at SYMA Consulting - Lead Auditor at LNE/GMED: Medical devices ISO13485:2003, ISO 13485:2016, CMDCAS, MDD (CE Marking), MDSAP - Medical Device Single Audit Program, ISO9001:2008, ISO9001:2015. - Senior QA Consultant Medical Devices at Emergo Group - ISO 13485 Instructor at BSI: Lead and Internal Auditor Trainings Past - ISO 9001 Auditor at DQS-UL Mexico - Compliance Leader at GE Healthcare - Supplier Quality Leader at GE Healthcare - Supplier Quality Engineer at General Motors Specialties: Quality Assurance ISO 13485:2003 and 2016 ISO 9001:2008 and 2015 Medical Devices regulations - CE Marking MDD, MDSAP, CMDCAS. Process Validation (IQ, OQ, PQ) Electrical Safety ISO TS 16949 Supplier Quality Management Supplier Auditing and Qualification

Country

mexico

City

naucalpan

Industry

hospital & health care

Skill

quality system, quality assurance, quality auditing, iso, iso 13485, supplier quality, quality management, capa, normas iso, root cause analysis, iso 9000, mejora continua, medical devices, continuous improvement, fda, quality control, cross functional team leadership, six sigma, fmea, ts16949, apqp, change management, supplier evaluation, leadership, seis sigma, program management, iso/ts 16949, control de calidad, quality systems, supply chain, ppap, supplier development, global sourcing, iso 14971, cambio organizacional, productos sanitarios, internal audit, 5s, spc, automotive, poka yoke, product quality, supplier quality management

Experience

sourcing compliance leader

ge healthcare mexico

2010-3 - 2011-1 · 11 mos

Implementation of EU best practices for Latin America's indirect sourcing activities.

quality engineer

valeo

1999-1 - 2001-1 · 2 yrs 1 mo

Product quality engineer for new product development and production.

lead auditor medical devices iso13485

lne/g-med north america

2013-1 - Present · 13 yrs 9 mos

* ISO 13485 QMS Audit * CE Marking for Medical Devices (MDD - European Regulation) * MDSAP audit * ISO 13485 CMDCAS (Canada) * IEC 60601 (electrical safety and EMC) , IEC 62304 (Software Lifecycle) * ISO 14971 Risk Management

iso auditor

dqs de méxico

2012-7 - 2013-7 · 1 yr 1 mo

ISO 9001:2008 certification audits

sourcing compliance leader

ge healthcare

2008-12 - 2010-1 · 1 yr 2 mos

Leverage lean methodology to deploy end-to-end sourcing compliance through EMEA (Europe Middle East & Africa – 74 Legal Entities) & Latin America, including due diligence on cash out processes, appropriate training programs, purchasing Cookbook and setting up appropriate control processes. Lead compliance projects through EMEA to mitigate quality, financial & legal risks, to drive base cost control and monitor overall application of deployed processes.

supplier quality modality leader

ge healthcare

2005-10 - 2008-12 · 3 yrs 3 mos

* Lead quality improvement plans of a European supplier base delivering GEHC plants worldwide. * Certified quality system auditor, for ISO 13485 & 9001 norms. * GEHC qualified Lead Auditor * Modality responsibility on Mammography: Set up strategies, priorities and projects monitoring for the supplier quality team on mammo supply chain.

supplier quality engineer

general motors

2001-1 - 2004-1 · 3 yrs 1 mo

* Follow up of direct material suppliers in Mexico. * Audits of production processes and quality systems. * Production capacity studies – real production capacity vs. contracted volumes . * Improvement workshops: Kaizen, Error Proofing, PFMEA, Control plan, Quality System Basics.

associate partner

mppi consulting

2013-5 - 2016-5 · 3 yrs 1 mo

senior qa consultant medical devices

emergo

2011-6 - Present · 15 yrs 4 mos

* Gap Analysis * QMS Redaction and Deployments. * Trainings: Intermal Audits ISO13485 and FDA QSRs

senior qa consultant at syma consulting

syma consulting

2011-1 - Present · 15 yrs 9 mos

* Certified Lead Auditor ISO13485:2003 & ISO13485:2016 * MDD * MDSAP * Certified Lead Auditor ISO 9001:2015 & ISO13485:2008 * Certified Lead Auditor ISO 9001:2008 with emphasis on ISO/TS 16949:2009. * Activities: * Quality Management System design, development and implementation. * Internal Auditing, preparation for external Audits * Tier 2 Audits, Quality System Audits and Process Audits * Supplier Qualification Services * Defect Management * Corrective and Preventive Action Plan, Root Cause Analysis, Workshops * Geographical Scope: Europe, North & Latin America.