Freelancer profile translated to English.

Description

Quality Engineer and M.Sc. in microbiology and immunology, I have held Quality Manager or Quality Control positions for almost 20 years within various companies designing and manufacturing medical devices (MD, IVD) in fields as diverse as infectious disease detection, interventional pulmonology, hemostasis, or the manufacturing of therapeutic antibodies. The implemented and maintained quality systems have met international standards (ISO13485, ISO9001) as well as international regulatory requirements (MDR, IVDR, 21 CFRs, SOR, kFDA).

A hands-on person, I aspire to share the skills and know-how that others have passed on to me in the service of improving the health and quality of life of our fellow citizens.

I can help you in the implementation of your short, medium, or long-term projects, whether they are national or international.

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Marseille (up to 50km), Lyon (up to 10km), Paris (up to 10km)

Consultant Freelance
Freelance Consultant
PHARMACEUTICALS INDUSTRY
September 2022 - Today (3 years and 9 months)
Marseille, France
During my past professional experiences, I have developed the following skills:

Implementation of ISO13485, ISO9001 Quality Management Systems
QMS Support: Management review, implementation of indicators, Root cause analysis, CAPA deployment.
Internal, Supplier, Traceability Audits.
Implementation of basic or advanced EDM document structure.
Management or support for ISO14971 risk analysis.
Support for client audits, Notified Bodies, Competent Authorities: Preparation, report analysis, and CAPA deployment.
Implementation and audit of production, Quality Control, storage, and shipping traceability.
Support for supplier selection and monitoring. Drafting of Quality agreements.
Quality Management Regulation Medical Devices iso9001 iso131485 Internal Audit supplier audit