Experience

FeetMe

• France
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality and Regulatory Engineer

  • Nov 2020 - Present

  Paris, Île-de-France, France - Actively ensured QMS compliance with ISO 9001, ISO 13485, IEC 62304 and IEC 62366 standards - Wrote and implemented new SOPs - Ensured a strong control of Design and Development documentation and monitored Change Control - Maintained DHF and DMR records - Managed Defects, Non-Conformities and CAPA resolution - Provided continuous support for Quality and Regulatory requirements implementation - Participated in various cross-departments projects and workshops - Performed… Show more - Actively ensured QMS compliance with ISO 9001, ISO 13485, IEC 62304 and IEC 62366 standards - Wrote and implemented new SOPs - Ensured a strong control of Design and Development documentation and monitored Change Control - Maintained DHF and DMR records - Managed Defects, Non-Conformities and CAPA resolution - Provided continuous support for Quality and Regulatory requirements implementation - Participated in various cross-departments projects and workshops - Performed MDR 2017/745 gap analysis and actively worked on the MDR transition of Feetme products - Managed communication with Notified Body and certification labs - Prepared and submitted necessary documentation for the extension of the CE mark under MDD 93/42/CE - Coordinated and participated to internal and external audits - Wrote Technical Files under MDD and MDR - Animated Risk Management activities and updated Risk Management files - Participated in Management Reviews - Prepared Post Market Surveillance Plans and Reports Show less



Pixel Factory

• Morocco
• Media Production
• 1 - 100 Employee

• Project Quality Engineer

  • Jan 2019 - Dec 2019

  Maroc Implementation of Quality Management good practices and approaches in both internal and customer relationship processes : Raise employees awareness of documentation control and quality management processes Tracking of non conformances and update of internal documentation



Aptar Digital Health

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Project Quality Manager

  • Feb 2016 - Nov 2017

  Région de Paris, France - Managed quality activities all along the development of medical device applications for diabetes patients - Prepare project quality documents and milestone reports - Verify the implementation of ISO 9001, ISO 13485 and GMP requirements - Manage non conformances resolution - Manage Change Controls - Assist project members with standards, processes and GMP expertise - Provide quality trainings to project members and new employees - Prepare and lead various internal… Show more - Managed quality activities all along the development of medical device applications for diabetes patients - Prepare project quality documents and milestone reports - Verify the implementation of ISO 9001, ISO 13485 and GMP requirements - Manage non conformances resolution - Manage Change Controls - Assist project members with standards, processes and GMP expertise - Provide quality trainings to project members and new employees - Prepare and lead various internal audits - Manage CAPA and customer complaints - Design and monitor processes KPI’s - Prepare and participate to external ISO certification audit. Show less



EFOR

• France
• Business Consulting and Services
• 700 & Above Employee

• Project Quality Consultant

  • Mar 2015 - Jan 2016

  Région de Paris, France Consultant at Voluntis as Quality project Leader involved in the development of Web and mobile medical device applications. My main responsibility was to: - manage quality activities all along the application development lifecycle. - Verify the implementation of ISO 9001, ISO 13485, IEC 62304 and IEC 62366 requirements - Plan and manage quality project milestones and deliverables - Plan and provide QA trainings to project members - Manage Non conformities, CAPA and… Show more Consultant at Voluntis as Quality project Leader involved in the development of Web and mobile medical device applications. My main responsibility was to: - manage quality activities all along the application development lifecycle. - Verify the implementation of ISO 9001, ISO 13485, IEC 62304 and IEC 62366 requirements - Plan and manage quality project milestones and deliverables - Plan and provide QA trainings to project members - Manage Non conformities, CAPA and change requests Show less



IMV Technologies

• France
• Biotechnology Research
• 100 - 200 Employee

• Quality Assurance Engineer

  • Jul 2013 - Jul 2014

  L'aigle - Preparared and participated to the ISO 9001 and ISO 13485 certification audits - Reviewed and writed quality documentation - Prepared and led various internal audits - Managed non-conformances - Provided internal trainings on GMPs, GDP, ISO and QMS - Project leader of EDMs (Electronic Documentation Management system) design and implementation: - Supplier management - Architectural design of the new QMS - Design and documentation of access… Show more - Preparared and participated to the ISO 9001 and ISO 13485 certification audits - Reviewed and writed quality documentation - Prepared and led various internal audits - Managed non-conformances - Provided internal trainings on GMPs, GDP, ISO and QMS - Project leader of EDMs (Electronic Documentation Management system) design and implementation: - Supplier management - Architectural design of the new QMS - Design and documentation of access rights, archiving and documents numbering processes - Writing of user manuals - Provide trainings and technical support to all users. Show less



IAV Automotive Engineering, Inc.

• United States
• Professional Services
• 200 - 300 Employee

• Quality Manager

  • Mar 2012 - Nov 2012

  Courbevoie, Ile de France Coordinated the ISO 9001 certification project Helped define the Quality Policy and goals with top management members Designed process map and performed gap analysis of missing documents and processes Wrote and reviewed various QMS documents (Quality Manual, SOPs, Templates, etc.) Monitored the internal deviations and non-conformance process Provided quality guidance on ISO 9001 expectations Led several internal audits and participated to the ISO 9001 certification Audit.



Septodont

• France
• Medical Equipment Manufacturing
• 700 & Above Employee

• Research And Development Engineer

  • Mar 2011 - Aug 2011

  Région de Paris, France Built new models for predicting the expiration date of injectable anesthetics Designed and monitored accelerated stability testing protocols Assessed the stability characteristics of different formulations Helped develop a Sulfite dosage methodology by UPLC Performed analytical tests and Wrote technical reports.



Université de Bordeaux

• France
• Education Administration Programs
• 700 & Above Employee

• Analytical Chemist - Laboratoire de chimie analytique - Phamacy University of Bordeaux

  • Nov 2010 - Feb 2011

  Région de Bordeaux, France Optimization & validation of an HPLC method for the determination of Artemether and Azithromycine - definition of experiments plans using multiple chromatographic parameters - documentation of analytical protocols and run of corresponding analysis - chromatographic data analysis and writing of analytical reports - coordination with formulation department



Servier

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Assistant

  • Jul 2010 - Aug 2010

  Casablanca Performed physicochemical QC testing on solid forms Reviewed QC procedures Monitored Stability tests follow-up.



Université de Reims Champagne-Ardenne

• France
• Education Administration Programs
• 700 & Above Employee

• Research Chemist

  • May 2010 - Jun 2010

  Région de Reims, France Synthesized “bisindolylisothiasolinones” molecules using palladium catalyst reactions with the aim of generating an antineoplasic activity Purification & Characterization of synthesized products using Chromatography (CC, TLC & HPLC) and spectroscopy (IR, NMR, MS) Built test protocols and wrote analytical reports.