Brigitte D. Email & Phone Number

Bordeaux, France

- Medical devices and pharmaceutical industry-ISO 13485, ISO 9001, cGMPs, 21 CFR Part 820- Demonstrated experience in audit techniques (IRCA certified auditor, notified bodies sub-contractor, Health Cannada, MDSAP)- ISO 13485, ISO 9001,Internal or supplier audits- Thorough understanding of local and international regulations-Regulatory registration-Technical files - Any Quality project management for improvement activities and GMP compliance

France, Usa (Nj), Switzerland

Spine business.30 people under responsibility-5 direct reportsNew Product Introduction Risk ManagementEquipment Qualification and process ValidationMicrobiology, Eto and Gamma sterilization, Cleanrooms monitoring, Batch releaseSuppliers managementComplaints, vigilances, recall monitoringRegulatory registrationCertification and/or inspection preparation and management (FDA, Notified Bodies, ANVISA, KMFDS etc.)

France

Corporate Quality Manager for French Subsidiary5 locations including Design, Manufacturing and distribution on French Market.Cardiovascular (class III products), Infusion Therapy, Continence Care, Urology, Stoma Care, Orthopaedics

France

Government Agency for Health and Medical Devices Quality Control

France