About Cyrine
French
Native or bilingual
English
Fluent
Experience
- CIE CONCORDE IMPORT EXPORT
On Malt
Outsourced Internal Audit ISO 13485MEDICALMay 2026 - May 2026Levallois-Perret, FranceConducting the internal quality management system audit according to ISO 13485 at Concorde Import Export, a manufacturer, importer, and distributor of medical devices, taking into account the applicable requirements of Regulation (EU) 2017/745 concerning medical devices (MDR). - EsaoteIndependent QSE ConsultantMEDICALOctober 2022 - Today (3 years and 8 months)Saint-Germain-en-Laye, France
Context:
French subsidiary of an international group specializing in medical devices (ultrasound scanners and MRIs), operating in a highly regulated environment, particularly regarding Regulation (EU) 2017/745 (MDR). Challenges included maintaining ISO 9001, ISO 13485, and ISO 14001 certifications, aligning with group requirements, implementing an occupational health and safety management system (ISO 45001), and structuring an CSR approach.Missions:
- Leading and improving the Quality, Safety, and Environment management system.
- Maintaining and securing ISO 9001, ISO 13485, and ISO 14001 certifications.
- Implementing an occupational health and safety management system (ISO 45001).
- QSE coordination between the French subsidiary and the group.
- Facilitating working groups, training teams, and coaching managers on ISO requirements.
Results:
- 0 non-conformities in 5 third-party audits (ISO 14001, ISO 9001, ISO 13485 - LNE, TÜV).
- ISO 45001:2018 certification obtained in 10 months, with no non-conformities.
- Structured and stabilized QSE system in a medical environment with high regulatory requirements.
- QualiCyIndependent Quality, Safety, and Environmental ConsultantCONSULTING AND AUDITSJune 2022 - Today (4 years)Paris, France
Context:
Engagements as an independent QSE consultant for SMEs and large companies (services, industry, insurance, engineering, private security), within the framework of ISO 9001, ISO 14001, and ISO 45001 certification projects, as well as internal audit missions and management system structuring.Two main types of services:- Support for the implementation and certification of ISO management systems
- ISO internal audits and one-off QSE missions (diagnosis, environmental assessment, DUERP)
Missions:
- Leading ISO 9001, ISO 14001, and ISO 45001 certification projects.
- Conducting ISO 9001, ISO 14001, and ISO 45001 diagnoses and developing compliance action plans.
- Process mapping and structuring the process approach.
- Risk analysis.
- Conducting environmental assessments.
- Developing and updating DUERPs.
- Assessing regulatory compliance in health, safety, and environment.
- Designing and redesigning QSE documentation systems.
- Defining and monitoring QSE performance indicators.
- Training and awareness-raising of teams on ISO requirements.
- Conducting ISO 9001, ISO 14001, and ISO 45001 internal audits (certified IRCA auditor).
- Analyzing non-conformities and managing corrective actions.
- Supporting clients during certification audits.
Results:
- Supported over 20 organizations in implementing and improving their QSE management system.
- Implemented compliant and operational management systems, adapted to the challenges of SMEs and large companies.
- Strengthened compliance levels and preparation for ISO certification audits.
- Contributed to the success of certification, surveillance, and renewal audits.
Reviews
Recommendations
These freelancer profiles also match your criteria
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Education
- Professional Master's in Integrated Management: Quality, Safety, and Environment (Level 7 diploma)Virtual University of Tunis (UVT)2020Formation complète en systèmes de management QSE couvrant les normes ISO 9001, ISO 14001 et ISO 45001, l’audit selon l’ISO 19011, le management des risques selon l'ISO 31000, l’analyse de données, le pilotage de la performance, la conduite du changement, la RSE, ainsi que l’amélioration continue et le lean management. Formation incluant des projets de mise en place de systèmes de management, avec une approche opérationnelle orientée structuration, conformité, performance et préparation aux audits de certification. Diplôme évalué par le centre ENIC-NARIC France au niveau 7 du Cadre européen des certifications (équivalent Master français - Bac+5).
Certifications
- CQI and IRCA Certified Auditor/Lead Auditor of Quality Management Systems ISO 9001DNV2024
- CQI and IRCA Certified Auditor/Lead Auditor of Occupational Health and Safety Management Systems ISO 45001DNV2025