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QA/RA Product & Project Manager Expert in Medical Device

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  • 08.10.2024

Kurzvorstellung

My name is Dieudonné M.. I have been a professional in the Medical Device Field for 20 years and am currently working as a consultant in the areas of R&D, Manufacturing, Quality, and Regulatory Affairs in Europe, North America, and Asia.

Qualifikationen

  • Artificial intelligence
  • Audition6 J.
  • Medizintechnik4 J.
  • Notify Body Auditor
  • Projektmanagement
  • Qualitätsmanagement / QS / QA (IT)5 J.
  • Technisches Projektmanagement9 J.
  • Technisches Qualitätsmanagement / QS / QA

Projekt‐ & Berufserfahrung

Notify Body
DQS MED, Frankfurt am Main
12/2019 – offen (5 Jahre)
Life Sciences
Tätigkeitszeitraum

12/2019 – offen

Tätigkeitsbeschreibung

ISO 13485 Certification Audits
MDSAP Audits
CE- Conformity Assessment (MDR /MDD Audits)
GMP Audits
Technical File Review

Eingesetzte Qualifikationen

Medizintechnik

Quality Assurance Specialist (Consultant)
Novartis Pharma, Basel
12/2019 – offen (5 Jahre)
Life Sciences
Tätigkeitszeitraum

12/2019 – offen

Tätigkeitsbeschreibung

- Manage a portfolio of assigned projects and provide functional expertise in the 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

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT)

Consultant Auditor
DQS Notified Body (Germany), Frankfurt
12/2018 – offen (6 Jahre)
Life Sciences
Tätigkeitszeitraum

12/2018 – offen

Tätigkeitsbeschreibung

ISO 13485 Certification Audits
MDSAP Audits
CE- Conformity Assessment (MDR /MDD Audits)
GMP Audits
Technical File Review

Eingesetzte Qualifikationen

Audition

Subject Matter expert Quality, R&D und Produktion
Stryker, J&J, Zimmer, Leoni, Philips, ......, Freiburg
1/2007 – 10/2016 (9 Jahre, 10 Monate)
Medizintechnik
Tätigkeitszeitraum

1/2007 – 10/2016

Tätigkeitsbeschreibung

Project Manager for UDI (Unique Device Identification)
Quality Assurance Manager
Project Manager DHF Remediation
Project Manager DHF Remediation
Quality management system expert

Eingesetzte Qualifikationen

Technisches Projektmanagement, Medizinische Messtechnik, Produktionstechnik (allg.), Qualitätssicherungssysteme

Zertifikate

Regulatory Affairs Manager International
2011
Qualitätsmanagement Auditor
2011
Qualitätsbeauftragter
2010
Six Sigma Greenbelt
2010

Ausbildung

Maschinenbau
Dipl.Ingeneiur (Uni)
2007
Karlsruhe
General Management
MBA
01/2
London (UK)

Über mich

My name is Dieudonné M.. I have been a professional in the Medical Device Field for 20 years and am currently working as a consultant in the field in areas of R&D, Manufacturing, Quality, and Regulatory Affairs in Europe, North America, and Asia.
My Projects involved working on products of classes I-II-III, Combination devices (drug-device), and in Vitro Diagnosis (IVDD/ IVDR). I am also providing support to several Notified Bodies in Europe, like DQS, TUV Nord, and SGS, as Lead Auditor and Technical Documentation reviewer for MDR, MDD, MDSAP, ISO 13485, and ISO 9001.
After graduating from the University of Karlsruhe (Germany) in February 2007 as a Mechanical Engineer specializing in Medical Technology and Mechatronics, I completed further studies in Executive Management at the University of Plymouth (Executive Management) and Business Management at both the University of Georg-Simon-Ohm University in Nurnberg and Zhejiang University in Shanghai (China).

Weitere Kenntnisse

found in profile qualification
Expertise in Business Management, Product Management, Production Management, Supply Chain Management.
- Proficient in ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11,
GAMP5, IEC 62304, IEC 82304, IEC 60601, IEC 62366; MDR 2017, UL 2900-1 & UL 2900-2-1; TIR57_AAMI; IEC
80601; ISO 10993-1; ISO 17664…
- Proficient in:
o MDD 1993
o MDR 2017 (Medical Device Regulations)
o IVDD
o IVDR 2017
o Clinical Evaluation
o Biocompatibility (Biological Safety Evaluation)
o Technical documentation
o CE-Conformity Assessment
o FDA 510 (K) Submission preparation
o Product Development
o Usability Engineering
o Risk Management
o FMEA (DFMEA, PFMEA, Use FMEA)
o Product Security Management (Cybersecurity)
o Quality Assurance
o Quality Management Requirements (Writing QMS Procedures)
o Quality control
o Project Management
o Process optimization
o Change control
o Auditing
o Qualification/ Process validation
o CAPA System (CAPA Investigation, Resolution, Mitigation measures)
o Clean Room Requirements
o Packaging

Persönliche Daten

Sprache
  • Französisch (Muttersprache)
  • Englisch (Fließend)
  • Deutsch (Fließend)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
2869
Alter
50
Berufserfahrung
22 Jahre und 8 Monate (seit 03/2002)
Projektleitung
10 Jahre

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