Yvan Chevrier

QA/RC Leader for the Lonay and Plan-les-Ouates sites Member of the site leadership team, Management Representative, PRRC Oversight of Quality Assurance, Quality Control, Quality Operations, Qualification/Validation, Training, Continuous Improvement, Regulatory Affairs, Supplier Quality and Microbiology Definition of the site Quality strategy in line with regulatory, normative and Corporate requirements KPI reporting to the management team Maintenance of the QMS in line with applicable standards and regulatory requirements Budget definition and control Team development and coaching

QA/RA Manager of the Operations and Sales entities in France & Italy QA/RA manager for a devices range made in Europe/Asia/North America Team management, 16 people QMS management according to the standards and regulations 92/42/CEE, ISO 9001, ISO 13485 and 21 CFR part 820 European test lab management, according to ISO 17025. MDR, VR and IR management with the local authorities CAPA Management (Capa Board management, action plans management) Continuous improvement Leader Regulatory skills and respect guarantor Quality and compliance guarantor in production, in the design phases, for the supplier quality and projects Monthly reporting to the EMEA HQ: customer PPM (33% decrease in 5 years), warranty cost (40% decrease in 5 years), suppliers PPM (10% decrease in 5 years)

Responsible for the quality of purchased finished products and components in advanced and mass production phases (180 suppliers) Supplier Audits (process and QMS) Team management, 3 people

Responsible of the purchased finished products according to the standards ISO TS16949 and ISO 9001 Suppliers Quality interface for 8 projects « captors and actuators » Management of the quality process in the project team. Responsible of the deliverables of each milestones and APQP steps (PPAP, Run at Rate, Audits …)

Contribute to the development of 35 production autonomous teams (277 people). Support the team deployment. Develop management project tools. Manage the training planning. Measure the autonomous level of the teams.

Quality management according to the standards ISO TS16949 and ISO 9001. Team management, 4 peoples. Customer complaints management (72 % reduction on 4 years). Internal defect management (70% reduction on 4 years). QMS management and customer/notified body audits preparation. FIEV audits realization. Audits management (product and workstation audits). Quality performance monthly review management Measurement and production equipments capability management. Problem solving team management. Process changes validation and new equipment validation