QA/RA Product & Project Manager Expert in Medical Device
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- 08.10.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
12/2019 – offen
Tätigkeitsbeschreibung
ISO 13485 Certification Audits
MDSAP Audits
CE- Conformity Assessment (MDR /MDD Audits)
GMP Audits
Technical File Review
Medizintechnik
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
Qualitätsmanagement / QS / QA (IT)
12/2018 – offen
Tätigkeitsbeschreibung
ISO 13485 Certification Audits
MDSAP Audits
CE- Conformity Assessment (MDR /MDD Audits)
GMP Audits
Technical File Review
Audition
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
Technisches Projektmanagement, Medizinische Messtechnik, Produktionstechnik (allg.), Qualitätssicherungssysteme
Zertifikate
Ausbildung
Karlsruhe
London (UK)
Über mich
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
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
- Französisch (Muttersprache)
- Englisch (Fließend)
- Deutsch (Fließend)
- Europäische Union
- Schweiz
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