Profilbild von Dieudonn Mbarga QA/RA Product & Project Manager Expert in Medical Device aus Delemont

Dieudonné Mbarga

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Letztes Update: 03.01.2024

QA/RA Product & Project Manager Expert in Medical Device

Abschluss: nicht angegeben
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (verhandlungssicher) | englisch (verhandlungssicher) | französisch (Muttersprache)

Dateianlagen

CV-Dieudonne-Mbarga-DM-Smart-Engineering-GmbH-2023_170423.pdf

Skills

  • Notify Body Auditor
  • Proficient in Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304
  • Proficient with:
    • Quality Assurance
    • Quality management requirements
    • Quality control
    • Technical documentation
    • FDA 510(K) Submission preparation
    • product development
    • project management
    • Process optimization
    • FMEA
    • risk management
    • Change control
    • auditing
    • qualification
    • CAPA system
    •  Medical Device Regulations
    • Clean room requirements
    • packaging
    • Process validation

Projekthistorie

07/2020 - bis jetzt
Quality Assurance Specialist (Consultant)
Novartis Pharma (Pharma und Medizintechnik)

- Manage a portfolio of assigned projects and provide functional expertise in area of responsibility for medical devices and combination products
- Provide Quality and Regulatory guidance in development projects of combination devices
- Write, review and approve deliverables (e.g. procedures, records, third party work, clinical trial material, components) to ensure GMP compliance
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize the impact on global supplies and patients - Release of medical devices for clinical studies and commercial use
- Perform inspections and audits

04/2020 - bis jetzt
Notify Body Consultant Auditor
TüV NORD (Sonstiges)

Field of action as an auditor:
- ISO 13485 Certification Audits GMP Audits CE
- Conformity Assessment (MDR /MDD Audits)
-Technical File Review

08/2019 - bis jetzt
Notify Body Consultant Auditor
DQS Med (Sonstiges)

Field of action as an auditor:
-ISO 13485 Certification Audits
-MDSAP Audits CE
- Conformity Assessment (MDR /MDD Audits) GMP Audits
-Technical File Review

Reisebereitschaft

Nur Remote verfügbar
I am willing to work in the EU, USA and Asia. I am flexible to travel
Profilbild von Dieudonn Mbarga QA/RA Product & Project Manager Expert in Medical Device aus Delemont QA/RA Product & Project Manager Expert in Medical Device
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