Freelancer profile translated to English.

Description

Hello,

Quality Assurance expert in medical devices, I can assist you in establishing compliance or creating your QMS for certification by a notified body.

Feel free to contact me ☎️

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Valbonne (up to 50km)

Laboratoire SHADELINE,
Quality Control Manager (Permanent Contract)
September 2013 - June 2017 (3 years and 9 months)
Mouans-Sartoux, France
Participation in Client and Certification audits (ISO13485 & ISO22716) Writing and updating quality procedures as well as batch records, releasing manufacturing batches, monitoring non-conformities, CAPA management. Continuous quality and process improvement approach. Quality Review of Design Changes.

Management of analyses for dermo-cosmetic, OTC, and Medical Device products and applications on raw materials, manufacturing batches, and finished products. Transverse management. Supervision of a Quality Control technician. Writing certificates of analysis. Management of equipment and consumables for the control and analytical development laboratory. Qualification and metrological monitoring of laboratory equipment.
GE Healthcare,
Lead QA Engineer (Permanent Contract)
MEDICAL
July 2017 - Today (8 years and 11 months)
Valbonne, France
Business :

Main responsibilities :
• QA Responsible for Manufacturing process.
• QA Representative for Design Change / Design Control.
• QA Core Team for Local NPIs.
• Management of Manufacturing NC/Investigation/CAPA.
• Providing leadership on implementation of new regulations/procedures.
• Mentoring cross-funtionnal teams (Manufacturing/Engineering) for implementation of new procedures/regulations.
• Developed templates to improve "ease-to-do" to Manufacturing teams.
• Support on external audits, Internal audits, OEM customer audits and MDSAP.
MDSAP Audit Quality Control ISO 13485 Quality Assurance
Laboratoire SHADELINE,
Quality Assistant (Permanent Contract)
June 2009 - September 2013 (4 years and 3 months)
Chemin de Mouans-Sartoux, Mouans-Sartoux, France
Analyses of dermo-cosmetic and OTC products and applications on raw materials, manufacturing batches, and finished products. Management of equipment and consumables for the control and analytical development laboratory. Qualification and metrological monitoring of laboratory equipment. Writing and updating quality procedures as well as batch records, releasing manufacturing batches, monitoring non-conformities, active participation in the implementation of GMP/GLP according to ISO 22716, ISO 17025, and ISO 9001 standards.
Obtaining BIO & Medical Device class I and II.a product accreditations.