Profileimage by Dieudonn Mbarga QA/RA Product & Project Manager Expert in Medical Device from Chur

Dieudonné Mbarga

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Last update: 23.07.2020

QA/RA Product & Project Manager Expert in Medical Device

Graduation: not provided
Hourly-/Daily rates: show
Languages: German (Full Professional) | English (Full Professional) | French (Native or Bilingual)

Attachments

Dieudonne Mbarga _Curricilum Vitae.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

Project history

07/2020 - Present
Quality Assurance Specialist (Consultant)
Novartis Pharma
Pharmaceuticals and medical technology
- 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 - Present
Notify Body Consultant Auditor
TüV NORD
Other
Field of action as an auditor:
- ISO 13485 Certification Audits GMP Audits CE
- Conformity Assessment (MDR /MDD Audits)
-Technical File Review

08/2019 - Present
Notify Body Consultant Auditor
DQS Med
Other
Field of action as an auditor:
-ISO 13485 Certification Audits
-MDSAP Audits CE
- Conformity Assessment (MDR /MDD Audits) GMP Audits
-Technical File Review

Time and spatial flexibility

I am willing to work in the EU,USA and Asia. I am flexible to travel

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