Freelancer profile translated to English.
Back to original languageAbout Yassine
Quality Consultant with 6 years of experience in regulated industries, working with companies of all sectors (industry, services, healthcare, etc.), with a particularly strong expertise in quality management systems (QMS) in the medical device (MD) industry.
I support companies in implementing, maintaining, and improving their Quality system: internal audits, external audit preparation, CAPA and non-conformity management, document control, and Quality training/awareness. My experience in the highly demanding and regulated MD environment provides a transferable foundation for securing compliance and reliable processes in other contexts.
French
Native or bilingual
English
Fluent
Spanish
Basic
Remote only
Primarily works remotely
Experience
- WandercraftQuality EngineerMEDICALMay 2023 - December 2025 (2 years and 7 months)Paris, France- Maintenance and improvement of the QMS according to ISO 13485; contribution to the preparation and maintenance of certification.- Alignment, adaptation, and extension of the QMS to 21 CFR Part 820 requirements, while remaining consistent with MDR 2017/745.- Conducting internal audits, supporting external audits, participating in management reviews, and monitoring actions.- Management of non-conformities and customer complaints; investigations and CAPA steering.- Document control and traceability; team training/awareness, quality onboarding.- Impact assessment and deployment of changes (temporary and permanent); continuous improvement / indicator monitoring.
- Groupe AirelQuality Safety Environment CoordinatorMEDICALAugust 2019 - April 2023 (3 years and 8 months)Champigny-sur-Marne, France- Implementation and management of the QMS across the group's 3 entities; definition of processes and structuring of documentation.- Implementation/management of quality documentation and metrology/calibration (traceability, compliance).- Planning and conducting internal audits, supporting external audits and management reviews; monitoring action plans.- Management of non-conformities and complaints; continuous improvement.- Annual evaluation of suppliers/subcontractors; performance and compliance monitoring.- HSE aspect: periodic maintenance monitoring, prevention (PPE/ergonomics), chemical risk management (SDS), risk assessment update, waste management/optimization and traceability.
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Education
- Master Control & QualityUniversity of Cergy-Pontoise2020Mention BIEN
- Bachelor of Science in Chemistry & BiologyUniversity of Créteil2018Mention BIEN
Certifications
- Internal AuditorFréa Formation