Recommended expert
Dieudonné Mbarga
External Auditor
Experience
Feb 2021 - Present
5 yearsSwitzerland
External Auditor
SGS Switzerland
- QMS implementation according to international standards
- ISO 9001 & ISO 13485 certification audits
- Environmental management audits according to ISO 14001 (training & application)
- Conducting audits in the DACH region (remote & on-site)
- Remote & on-site audit experience (EU, DACH, APAC)
Apr 2020 - Present
5 years 10 monthsExternal Auditor
TÜV NORD CERT GmbH
- Audits according to ISO 13485, MDR, MDSAP
- Reviewing technical documentation and monitoring CAPA
- Familiar with certification processes according to ISO/IEC 17021
Aug 2019 - Present
6 years 6 monthsExternal Auditor
DQS Notified Body
- Conducting internal and external audits according to ISO 9001, ISO 14001, ISO/IEC 17021, ISO 19011
- Conducting ISO 9001 & ISO 13485 certification audits
- Audits for CE-MDR conformity assessments (MDD, MDR, MDSAP)
- Creating audit plans and conducting full audit cycles
- Creating complete audit reports and action plans
Summary
Certified and experienced Lead Auditor with over 20 years of international experience in quality management systems and auditing. Extensive project work at notified bodies such as SGS, DQS, TÜV NORD. Specialized in audits according to ISO 9001, ISO 14001, ISO/IEC 17021, ISO 19011 as well as consulting and recommending improvement measures.
Skills
- Conducting Internal And External Audits According To Iso 9001, Iso 14001, Iso/iec 17021, Iso 19011
- Creating Complete Audit Reports & Action Plans
- Acting As External Auditor At Dqs, Tüv Nord, Sgs (Lead Auditor)
- Process Consulting & Qms Implementation According To International Standards
- Remote & On-site Audit Experience (Eu, Dach, Apac)
- Lead Auditor – Iso 9001 (Dqs, Sgs, Tüv Nord)
- Lead Auditor – Iso 14001 (Sgs, Dqs – Environmental Management)
- Certified Auditor According To Iso/iec 17021 (Certification Systems)
- Continuing Education & Audit Training According To Iso 19011
- Validation & Risk Management According To Iso 14971, Iso 27001, Iso 45001, Iso 50001
- Developing & Structuring Qms Systems For Pharmaceutical And Technical Companies
- Consulting In Audit Preparation, Capa Processes, Improvement Measures
- Supporting Regulatory Inspections, Conducting Remote Audits
- Ms Office
- Sap
- Caq
- Easy Dms
- Audit Platforms: Trackwise, Veeva Vault, Jira, Confluence
- Documentation Systems: Xeri, Catsweb, Doors
Languages
German
AdvancedEnglish
AdvancedFrench
AdvancedEducation
Karlsruhe Institute of Technology (KIT)
M.Sc. Mechanical Engineering · Mechanical Engineering · Karlsruhe, Germany
Nuremberg University of Applied Sciences & Zhejiang University (China)
Business Management · China
University of Plymouth (UK)
Executive Management · Plymouth, United Kingdom
Certifications & licenses
Certified Auditor For ISO/IEC 17021
Lead Auditor For ISO 14001
Lead Auditor For ISO 19011
Lead Auditor For ISO 9001
Lead Auditor For ISO/IEC 17021
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