Freelancer profile translated to English.

Description

Quality and certification engineer with 12 years of experience, I am passionate about engineering in all its forms: from the rigor of standards to the resolution of concrete technical challenges.

I have supported companies in demanding projects:

- ISO 9001 and ISO 13485 certification for quality management systems in SMEs.

- CE marking compliance for connected medical devices.

- IEC 62368-1 certification for humanoid robots.

- Deployment of cosmetic GMP (ISO 22716) in a laboratory specializing in natural cosmetics.

My approach combines technical rigor and collaboration with teams from various backgrounds. I am particularly involved in identifying applicable product standards (European regulation) and supporting the implementation of quality management systems.

Availability: Mainly remote work, with occasional travel possible in Île-de-France (Paris and the southern suburbs of Paris).

Languages

French
Native or bilingual

Workplace preferences

Can work on-site

Boulogne-Billancourt (up to 10km)

Ti Kosmeo
Founding President
FASHION AND COSMETICS
January 2022 - Today (4 years and 7 months)
Boulogne-Billancourt, France
Natural cosmetic formulation:
- Design and development of products that comply with standards and customer expectations.
- Regulatory compliance: Application of the requirements of European Regulation 1223/2009 to ensure product safety and legality.
- Management of Product Information Files (PIF): Verification of their completeness and compliance.
- Implementation of Good Manufacturing Practices (GMP): Deployment and optimization of laboratory processes to ensure quality and traceability.
ISO 22716 European Regulation 1223/2009
SoftBank Robotics Europe
Certification Engineer
TECH
June 2019 - March 2022 (2 years and 10 months)
paris
• Ensure the compliance of design and industrialization with regulatory and normative requirements related to target sales countries.
• Analyze the robots' environment and architecture, analyze applicable standards for this architecture, and recommend design and industrialization rules.
• Participate in test plans to include certifying tests during the product development phase.
• Manage relationships with certification laboratories: participate in test execution, conduct compliance analyses.
• Monitor the evolution of regulations, standards, and guides applicable to the company and its robots, analyze impacts, and ensure internal communication of identified new requirements.
IEC 62368-1
SRETT
Quality Director
INTERNET OF THINGS (IOT)
October 2014 - June 2019 (4 years and 8 months)
Région de Boulogne-Billancourt, France
• Redesign of the Quality Management System (QMS) to adapt to SRETT's evolving activities and maintain ISO 9001 & ISO 13485 certifications.
• Organization and facilitation of internal audits to evaluate processes.
• Facilitation of system reviews with different teams to continuously improve the quality management system.
• Compilation of technical files for obtaining CE markings.
• Regulatory monitoring in the field of SRETT's activities: Radio Equipment, Medical Devices.
• Engagement with the notified body for the maintenance of ISO 13485 and ISO 9001 certifications of the QMS and CE markings of medical devices.
ISO 9001 ISO 13485 medical device GDPR