Freelancer profile translated to English.
Back to original languageAbout Yva
After 10 years in medical devices (including 5 years in class III), I support companies in their audits and quality systems with one conviction: it is the teams that bring quality to life, the system must serve them.
🔍 ISO 13485 Audits
Short assignments, 1 to 5 days: on-site, supplier, internal, certification preparation
⚙️ Quality Support
Long-term part-time assignments, 2 days/week: QMS performance and efficiency, Gap Analysis, CAPA management, complaints, non-conformities
My added value: transforming regulatory requirements into fluid, accessible, and truly useful processes for operational staff.
✅ The result: a compliant QMS, but above all a living, integrated, and performance-generating one.
📍 Based in the Ain region, I operate in Rhône-Alpes, the Swiss border area, and Paris.
French
Native or bilingual
English
Fluent
Can work on-site
Bourg-en-Bresse (up to 20km), Paris (up to 20km), Genève (up to 20km), Lyon (up to 50km), Annecy (up to 50km)
Experience
- SanQualMedQuality ConsultantCONSULTING AND AUDITSJune 2025 - Today (1 year and 2 months)Conducting supplier, internal, and ISO 13485 preparation auditsSpecialization in on-site audits: production, traceability, SOPs, production batchesOperational quality management: CAPA, complaints, non-conformities, continuous improvement.
- FX SolutionsProduct Quality ManagerBIOTECHJune 2021 - February 2024 (2 years and 8 months)Bourg-en-Bresse, FranceManagement of Non-Conformities, CAPA, complaints, and Change Control.Quality monitoring and supplier audits (on-site & focused).Quality indicator management
- ChronolifeQuality ManagerBIOTECHAugust 2018 - June 2021 (2 years and 10 months)Paris, FranceCreation, BSI certification, and maintenance of the quality systemCreation of the quality system at the final manufacturerQuality monitoring and supplier audits (on-site & focused).
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Education
- Internal and External Auditor Certification ISO 13485 and MDRCertification Auditeur Interne et Externe ISO 13485 et MDR
- Engineering Degree specialized in Quality and ProductionSchool of Industrial Biology (EBI)2012Diplôme d'Ingénieur spécialisé en Qualité et Production