Freelancer profile translated to English.
Back to original languageAbout Helene
I intervene on a part-time basis as:
- AUDITOR for a notified body issuing CE marking for medical devices on the ISO13485 and MDR standards
- external consultant assisting medical device manufacturers in setting up their QMS and MDR files.
Enriched by my professional experiences in quality manager and production manager roles within the medical device environment, I now provide support and pragmatism to organizations with specific or expertise-based needs in the following areas:
- compliance with quality regulations and standards (ISO13485, 14971, 62304, 62366...)
- process improvement and implementation of structuring tools (DMS, ERP...)
- conformity assessment (internal audit)
- training on quality standards
My scope of expertise includes regulations in EUROPE (MDR) and the USA (21 CFR).
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- HeVeAudit & Quality Consultant - Medical Devices/ External Auditor for CE markingMEDICALNovember 2021 - Today (4 years and 7 months)1. External auditor for a notified body (CE marking-MD)2. Internal and supplier auditor ISO 134853. QMS Implementation / Compliance ISO 13485, EU MDR, 21CFR PART 8204. Risk Management5. Certification preparation, audit follow-up, CAPA6. Training
- MICROPORT CRMQuality Engineer - Product Development ExpertMEDICALSeptember 2020 - September 2022 (2 years)Clamart, FranceFor a manufacturer of active implantable medical devices, class III:1. Quality member of product development teams and quality support for geographic expansion projects (Japan, Australia, USA, Canada, Korea)2. Improvement and management of the new device development process3. Management and coordination of quality resources assigned to new product development4. QMS training for new hires5. Internal auditor
- MICROPORT CRMQuality engineerMEDICALAugust 2018 - September 2020 (2 years and 1 month)For a manufacturer of active implantable medical devices, class III:1. Quality support for the design projects of cardiac defibrillators, pacemakers, and application software2. Preparation and review of technical file deliverables for defibrillators for MDR submission (Risk Management Analysis and file, compliance matrix, traceability matrix, GSPR, verification and validation document, PMS plan…)3. Management of design change reviews for the active implantables line4. Management of CAPAs and non-conformities for the cardiac defibrillator line5. Quality support for design transfer activities and manufacturing process validation (bonding and SMT processes)6. Participation in the development and review of product labeling7. Internal auditor
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Education
- Master 2 (M2), Audit and consultingILIS Faculty of Health Engineering and Management2005Master 2 (M2), Audit et conseil
- ISO 13485:2016 RequirementsGMED2017