Freelancer profile translated to English.
Back to original languageAbout Stéphanie
Hello and welcome to my profile!
An Industrial Engineering graduate and IRCA ISO 9001 Lead Auditor, I have been supporting industrial companies for over 10 years in structuring, optimizing, and certifying their quality management systems (QMS).
My multi-sector experience has allowed me to develop in-depth expertise in sectors with strict regulatory requirements:
- - Automotive (IATF 16949),
- - Medical (ISO 13485),
- - Electronics
- - Maritime (Marine Class Approval).
Today, as an independent consultant, I intervene proactively and pragmatically to meet your quality challenges:
🎯My Areas of Expertise:
Why work together?
Curious, rigorous, and highly adaptable, I quickly integrate into your teams and technical environments. My goal is to provide you with immediate operational support, solution-oriented, to embed quality into your daily production without burdening your processes. Let's discuss your next project!
Stéphanie
English
Fluent
German
Basic
French
Native or bilingual
Can work on-site
Roches-lès-Blamont (up to 20km)
Experience
- STETHOSQuality Consultant – Creation of Documentary SystemPHARMACEUTICALS INDUSTRYDecember 2023 - December 2023 (1 month)Targeted intervention to structure the documentary system and resolve a major non-conformity following a certification audit.*Documentary Engineering:Design, writing, and full deployment of the company's new Quality Manual, in full compliance with regulatory requirements.*Crisis Resolution & Audit:Analysis of gaps identified in the previous audit, implementation of appropriate corrective actions, and successful resolution of the non-conformity with the certification body.
- CRYOSTARMarine Class Approval Engineer & ConsultantAVIATION AND AEROSPACEMay 2023 - December 2023 (8 months)Mulhouse, FranceOptimization and management of the complete certification process for complex industrial equipment for the maritime sector.*Process Optimization:Audit, redesign, and adjustment of the inter-departmental certification process to streamline internal operations.*Class Society Relations:Technical and commercial interface with major international classification societies (Bureau Veritas, Lloyds Register, DNV, ABS, KR, CCS) until certifications are obtained.*Lifecycle Management:Regulatory watch on applicable standards, management of material modifications (after-sales service), and handling of 5-year renewals.
- TURCK DUOTECCustomer Quality & Audits OfficerMEDICALOctober 2017 - February 2023 (5 years and 4 months)Delémont, SwitzerlandOperational management of customer quality, regulatory compliance, and the audit system in a demanding industrial environment.*Management System & Tools:Complete creation of the process, procedures, and operating methods for customer complaint management. Structuring of QRQC rituals (Flash 30).*Audits (ISO 9001 & ISO 13485):Planning, management, and follow-up of internal audit action plans and rigorous preparation for customer and certification audits (ATEX products).*Compliance & Homologation:Management of regulatory certification files (REACH, RoHS, CMRT) and technical validation of customer requirements for homologation.*Tools:Optimization and improvement of the configuration of QM01/QM02 transactions in SAP.
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Education
- BAC STI Mechanical Engineering, Wood OptionLycée Louis Couffignal2006mécanique production bois automatisation
- Master 2 Industrial EngineeringUniversity of Strasbourg2013Lean Manufacturing Qualité Logistique