Experience

MDoloris Medical Systems

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality manager

  • Sep 2020 - Present

  Loos, Hauts-de-France, France Mains achievements : - Obtention of ISO 13485:2016 certification with a new notify body (BSI) and QMS conformity assessment regarding MDR 2017/745 requirements - Participation in obtaining the CE marking certification under MDR 2017/745 - Significant reduction in the number of nonconformity raised during third party audits (-80%) and of their processing time - Total redo of some major processes and of their associated interactions and KPIs - Implementation of a new reinforced… Show more Mains achievements : - Obtention of ISO 13485:2016 certification with a new notify body (BSI) and QMS conformity assessment regarding MDR 2017/745 requirements - Participation in obtaining the CE marking certification under MDR 2017/745 - Significant reduction in the number of nonconformity raised during third party audits (-80%) and of their processing time - Total redo of some major processes and of their associated interactions and KPIs - Implementation of a new reinforced internal audit process Tasks : - Management of the QMS, its processes and activities following ISO 13485, MDR 2017/745 and MDSAP requirements (21 CFR Part 820, RDC ANVISA 665/2022, MHLW MO 169, TG(MD)R Sch3, Health Canada) - Project tracking and coordination of Quality and Regulatory Affairs department - Primary contact during third party audits and answers to raised deviations - Participation of interservice activities (risk management, design reviews, HR, etc.) - Collection, analysis and follow-up of nonconformities and complaints - Selection, assessment, and audit of suppliers - Research, analysis and reporting of quality management measurement criteria (indicators, trend report, etc.) - Planification and realization of management reviews - Codification, control and dissemination of quality documents and records - Corrective and preventive actions follow-up - Control of product release and traceability Show less



Era Consulting

• Medical Device Consultant

  • Feb 2023 - Present

  Lille, France Services offered - Internal or mock audits (of the system or on specific processes) - Assistance on answers and follow-up of nonconformities issued by a notified body - Specific consultancy mission depending on the needs



MDoloris Medical Systems

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality and Regulatory Affairs Support

  • Feb 2020 - Jul 2020

  Loos, Hauts-de-France, France Establishment and update of regulatory files (CE mark and FDA) Planification and realization of the management review Participation in the implementation of MDR 2017/745 and MDSAP (Medical Device Single Audit Program)



MDoloris Medical Systems

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality and Regulatory Affairs Support

  • Apr 2019 - Sep 2019

  Loos, Hauts-de-France, France Formalization of regulatory requirements in the QMS (distribution, training) Data management using VBA and Power BI, and implementation of dashboards



NongLam University

• Chemical Manufacturing
• 100 - 200 Employee

• Laboratory technician in plant technologies

  • Apr 2017 - Jun 2017

  Vietnam Internship subject : "Screening molecular markers to differenciate phytopathogenic fungi" Conferences and international meetings