Freelancer profile translated to English.

Description

Quality Manager with over 9 years of experience in establishing and managing quality management systems in demanding industrial environments – aeronautics, medical, automotive. Solid expertise in developing quality plans, risk management, structuring project management frameworks, and leading cross-functional teams. Recognized for a pragmatic approach, the ability to translate quality requirements into concrete and applicable processes, and a keen sense for transverse facilitation.

Industry field of expertise

Languages

French
Native or bilingual
English
Native or bilingual

Workplace preferences

Can work on-site

Paris (up to 20km)

Gleamer
Quality Manager
MEDICAL
June 2023 - June 2025 (2 years)
- Developed and deployed the project quality plan and risk management plan covering the entire product development lifecycle – from R&D to commercialization – in compliance with ISO 13485 and EU MDR standards, with no major non-conformities during notified body audits.
- Structured the project's applicable frameworks: management plan, management specification, documentation and configuration management plan, change control procedures – ensuring the consistency and traceability of all project deliverables.
- Led the programmatic risk analysis in collaboration with engineering and product teams, integrating continuous review mechanisms aligned with product iterations – reducing documentation discrepancies by 40%.
- Defined and monitored project quality indicators (CAPA closure rate, recurring non-conformity rate, resolution times), and provided dashboards for operational management decision-making – improving audit readiness by 30%.
- Supported engineering and product teams as a quality facilitator: training on requirements, leading milestone reviews, and deploying procedures with a focus on rigorous and operational application.
- Contributed to obtaining MDSAP certification by leading inter-team remediation plans and ensuring compliance with international regulatory directives.
Analyse de risques gestion des plaintes Management de la qualité Amélioration continue QA testing
Thales
Project Quality Manager — Cybersecurity Program
June 2022 - December 2022 (6 months)
- Developed and implemented quality milestones and programmatic risk reviews for a multidisciplinary development program (mechanical, electronic, software), improving validation milestone adherence by 20%.
- Contributed to project structuring by defining the activities of each stakeholder, phase exit criteria, and quality control points – in direct interaction with the project manager and cross-functional teams.
- Managed corrective action plans to prevent development end-stage deviations and reduce rework during system integration phases.
Management de la qualité Analyse de risques Gestion de projet Gestion de configuration Comité de pilotage
GE Healthcare
Supplier Quality Engineer & Process Manager
HEALTH AND WELLNESS
November 2017 - May 2022 (4 years and 6 months)
- Managed the quality performance of a portfolio of over 400 industrial suppliers – qualification, non-conformity management (8D/CAPA), on-site audits, and closure verification – with no critical deviations over three consecutive audit years.
- Conducted over 40 internal and supplier audits according to ISO 13485 and FDA QSR standards, leveraging lessons learned to feed best practice guides and supplier improvement plans.
- Reduced recurring non-conformities by 35% through systematic application of problem-solving methods (8D, 5 Whys, root cause analysis) and deployment of preventive action plans.
- Improved supplier delivery performance by 40% by implementing quality dashboards, structured performance reviews, and a supplier rating system.
- Supported the industrialization of new products by qualifying critical suppliers, validating process controls, and ensuring readiness for production.
Gestion fournisseurs Management de la qualité Pilotage de processus Surveillance de la performance Actions correctives et préventives