Freelancer profile translated to English.

Description

Quality engineer by training, currently working in an industry specializing in medical devices. I have worked in the pharmaceutical and construction sectors.

Please contact me if you wish to know more.

Thank you

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Tours (up to 50km), Paris (up to 100km), Lyon (up to 100km), Bordeaux (up to 100km), Toulouse (up to 100km)

LINET France
QHSE Manager
PHARMACEUTICALS INDUSTRY
March 2024 - Today (2 years and 5 months)
Tours, France
Manage the QMS according to ISO 13485, 14065
- Management review
- Internal/external audits
- Monitoring market launch of medical devices
- NC CAPA management
- Regulatory watch
- Process review
- Document system management
- Microbiological monitoring
- Qualification/Validation
.......
Manage the HSE system

- Safety induction
- Update of the single document monitoring
- Safety risk awareness
- Accident monitoring
- Accident analysis + preventive actions
ISO 13485 14065 NF EN 14065 ISO 14971 45001
AEG PS
Quality & HSE Consultant
ENERGY AND UTILITIES
March 2023 - Today (3 years and 5 months)
Tours, France
Implementation of an Integrated Management System (Quality and HSE for ISO 9001 and MASE certification)

Obtained certifications,

- Definition of processes, process mapping, Quality Policy, Objectives....
- Formalization of process sheets + associated documentation (Activities, procedures, instructions....)
- Risk analysis, preventive actions
- Definition of an NC processing procedure
- Management of internal audits
- Management review
.....
ISO 9001 MASE framework
Essity
Quality and Regulatory Affairs Specialist
MEDICAL
October 2021 - Today (4 years and 9 months)
Monitoring of the quality system applied to medical devices
Regulatory watch
Monitoring and compliance with MDR
Writing of procedures related to regulatory affairs
Coordination of the preparation of marketing authorization applications
Technical documentation
Post-market surveillance
IQ OQ PQ validation
Implementation and deployment of enablers (Facilitators/Best practices)
Support and assistance to other departments on quality, regulatory & environmental aspects
Implementation of 14001