Freelancer profile translated to English.

Description

✓ What I do:

● I quickly assess the situation and impartially identify priorities.

● I optimize processes using quality tools and my technical skills: it's not about changing everything, but about putting things back in their right place.

● I propose a clear, structured, and sustainable action plan, aligned with regulations and quality tools.

● I organize KPIs, management reviews, and relevant indicators, using the right quality tools.

● I train teams on existing tools (LMS, Workday Learning, Cornerstone, GED, SharePoint, Power BI, Wrike, Office, ERP, Qualitysas, Odoo…).

● I advance projects in a few months that would often take a year or more, staying focused on the essentials and the needs of the teams I support.

→ Achievements

● 6 agencies certified ISO 9001 v8 in 2 years, a real asset for ISO 13485.

● 400 people trained since 2021: ISO 13485, MDR 2017/745, GMP, GDP, HSE.

● Implementation of QHSE systems and DMAIC methods.

● 3 plants deployed with the 5S method.

● 3 sites with controlled metrology.

● CAPA processing times reduced by 50%.

● 13 years of managing action plans, transverse communication, supporting teams with flexibility and empathy, conducting audits, training, and management reviews, with a human-centered and recognition-focused approach.

My values: Ethics, loyalty, confidentiality, adaptability, and curiosity.

● Between missions, I train, evolve, recharge, and elevate my performance level.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Vietnamese
Conversational

Workplace preferences

Can work on-site

Grenoble (up to 50km), Lyon (up to 50km), Paris (up to 50km), Genève (up to 50km), Aix-en-Provence (up to 30km)

Roche Diagnostics
Quality System Coordinator
January 2025 - July 2025 (6 months)
Grenoble, France
Merger of Roche Diabetes and Roche Diagnostics documentation.
✓ Document management without an EDM system: harmonization of processes and quality references.
✓ Technical coordination across departments (Medical, Legal, QHSE, SAP ERP, Sales, Marketing, Logistics, Metrology).
✓ Implementation and facilitation of quality review and documentation progress meetings.
✓ Structuring of the document hierarchy and optimization according to the ISO 9001 standard.
✓ Contribution to the 5S project to support management in improving organization and performance of the document management process through the proposed Flow Diagram method.
✓ Negotiation and retrieval of the key supplier management file for the Supplier Quality Manager.
✓ Follow-up, reminders, and recognition of internal stakeholders, using a step-by-step approach.
✓ Team awareness and training on the use of Google Workspace to facilitate team integration and change management.
ISO 9001 Project Management QMS
limatech
Quality Manager
AVIATION AND AEROSPACE
October 2023 - July 2024 (9 months)
Isère, France
• Maintained EN9100, Part 21G, and DOA certifications, with reporting to executive management.
• Created and implemented quality KPIs for managing three regulatory frameworks.
• Advised CEO on management tools and governance rituals.
• Deployed 5S, internal audits, SIM (short interval management), Lean tools. . Conducted Lean training and launched an internal training plan for a critical machine.
• Assessed, qualified, and audited suppliers; direct contact with critical subcontractors.
• Managed documentation through QSAAS.
• Led actions via WRIKE.
• Analyzed key employee motivation and implemented a retention plan.
• Contributed to security management; Improved metrology function and suggested a certified service provider.
• Liaised directly with management, R&D, and production to ensure quality and tech teams alignment.
• Shared expert contacts to support start-up growth.
EN9100 PART21G Audit Project Management Supplier Management
Medtronic
QA Specialist
MEDICAL
August 2022 - June 2023 (10 months)
Grenoble, France
Daily use of English . Conducted R&R audits for operational control and quality alignment . Cut service budget Updated documentation Worked with the design office to improve product design for ISO 13485 compliance Delivered 40+ ISO 13485/GMP training sessions to 200+ employees .
• Boosted training KPI to 95% through process improvements Created and rolled out structured onboarding for new hire . . .
• Introduced 3D control method to reduce production NC Optimized metrology: - 40% time, reduced costs . Tools: Cornerstone (LMS), Power BI, SharePoint, MS Office.
GMP MDR 2017/745 21 CFR Part 820 ISO 13485 Bilingual English