Experience

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  Stryker

  Jan 1999 - Jan 2007

  - Responsible for planning and directing Quality Management System - Manage continual improvement processes for increasing customer satisfaction and company performance - Regulatory Affairs Management – Healthcare- Projects management & Change Management - Ensure the QMS harmonization between 2 sites after company acquisition - Manage post-marketing vigilance system on the French market: Products Complaint Handling and Products Field Actions Handling

  • RAQA Manager

    Jan 2003 - Jan 2007

  • RAQA Associate

    Jan 1999 - Jan 2003
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  Ethicon, inc.

  Jan 2007 - Jan 2013

  Quality & compliance director

  - Manage Quality Assurance and Quality Control Department (24 employees with 4 direct reports) based ISO13485- Ensure that high quality is maintained throughout the organization in accordance with Corporate Policies and Regulatory Requirements- Manage continuous improvement processes for increasing company performance and customer satisfaction - Establish and manage Quality Control Systems - Release Raw Materials and Finished Products (Class III product - EEC93/42 directive) - Projects management & Change Management Voir moins

• 

  Albéa group

  Jan 2014 - Jan 2018

  Quality,& methods manager - corporate

  - Define with Corporate Quality teams the Quality Policy and Quality targets according to market requirements, customer expectations, and quality performance. - Promote, deploy and support the implementation of Albéa Quality strategy within Dispensing product line for customer satisfaction and business development- Manage projects relating processes or services or products / Problem solving. - Support New Product Development Process NPD- Quality representative including Top-Down and Bottom-up reporting and escalation process. Voir moins

• 

  Laboratoire puressentiel®

  Jan 2018 - Jan 2019

  Head of quality department

  Implement Quality Management System and Quality culture to achieve initial ISO 9001 certification

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  Reactive executive - leader en interim management

  Jan 2020 - Jan 2021

  Raqa director

  Support companies to manage Quality crisis, to prepare external audits, to manage CAPA actions plan, to ensure continuity plan considering Covid 19 context.

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  Safe orthopaedics

  Jan 2021 - now

  Raqa director

  - Project management to transfer final cleaning and packaging processes from 3 subcontractors to 1 (QA agreement, risk management, process qualification, product safety and compliance including Gamma sterilization and biocompatibility) - Define the RA strategy for MDR implementation (class IIa and IIb products)- Recruitment and development of new RAQA teams