Industry Facilitator and Quality Assurance Services in Support of e.g. Medical Device Manufacturing
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- 8001 Zürich
- Weltweit
- de | en | fr
- 31.10.2024
Kurzvorstellung
Electrical Engineering – Project Management – Quality - QMS – Leadership
Qualifikationen
Projekt‐ & Berufserfahrung
7/2023 – 10/2024
TätigkeitsbeschreibungRequirements Engineering; Riskmanagement; Design; Prozess; Montage; Dokumentation; Mechanik, Optik, Elektronik
Eingesetzte Qualifikationen8D Report, Business Process Reengineering (BPR), Compliance management, Design (allg.), Fehlermöglichkeits- und -einflussanalyse (FMEA), Interim Management, Lieferantenmanagement (allg.), Produktdesign
3/2015 – 6/2021
Tätigkeitsbeschreibung
Interim leading of the entire Quality Management (QA/ QE/ QC) to keep the ISO 13485 Quality Systems running, after the company got acquired by an US group. This includes audit- and people-management for CE marked Laser- & IVD-Equipment as well as Catheters and Stents.
Leading the merger of ISO 9001/ 13485 Quality Systems, after company acquisition, including regulatory clearing for compliance for the CE marked IVD Handling Robots.
Filmen
10/2014 – 12/2022
TätigkeitsbeschreibungDesign and executing assessments of Business-, Process- as well as Product-Risks following ISO14971; using FMEA- and Validation-Methodology. Planning and follow up of mitigation measurements e.g., in Robotnik.
Eingesetzte QualifikationenRisikomanagement
6/2012 – 5/2020
Tätigkeitsbeschreibung
Leading FDA, EU-NB or ANVISA inspection to get market access with products.
Preparing a major registration change in Russia, together with the Moscow marketing organization.
Managing registrations within Germany (BfArM/DMIDS) and set-up processes regarding MDR with EudaMed.
Field Action management and communication with Authorities for Medical Device Recalls.
Regulatory Affairs
9/2007 – 4/2023
Tätigkeitsbeschreibung
Design control activities for several well-known Medical Device and Pharmaceutical firms, using their own Design & Development Processes; Following Project Management Methodology for the Business aspects.
DHF Reviewer (for FDA audit readiness programs and active as notified body Auditor ISO 9001 & -13485 as well as MDR/MDD 93/42, for many different Businesses and Products.
Forschung & Entwicklung
5/2007 – 10/2015
Tätigkeitsbeschreibung
Production of combined medical devices for GSK’s asthma treatment program in responsibility as Head of Quality.
Evaluation and assessment of potential Contractors as well as transfer and design control in an international project for a new Novartis drug delivery system.
Pharma / Kosmetik
9/2004 – 3/2021
TätigkeitsbeschreibungSupplier and CMO contract management, assessments/ audits regarding validation/ qualification requirements for critical processes, within medical device production and food packaging, around Europe and the US.
Eingesetzte QualifikationenLieferantenmanagement (allg.)
9/1995 – 4/2023
Tätigkeitsbeschreibung
Management Systems: Sat in place, maintained, and improved many Systems from scratch, complying to ISO 9001; -13485; CFR 820; -210; -211; cGMP.
Compliance Management in the Medical Device Industry. Global upgrade of (8-D) CAPA-, Complaint- and Field Action- Management, including new Processes- & Software roll out.
Qualitätsmanagement / QS / QA (IT)
8/1977 – 12/1999
Tätigkeitsbeschreibung
Berufslehre und Weiterbildung als Elektroinstallateur.
Elektro-Projektleitung im Anlagenbau in Europa.
Lehrmeister von 130 AzuBi davon 40 direkt unterstellt.
Qualitäts- Umwelt- und Arbeitssicherheits-Verantwortlicher in einer 1000-Mann ABB-Gesellschaft.
EFQM-Business Excellence Assessor im ABB-Konzern.
Aus- / Weiterbildung, Qualitätsmanagement / QS / QA (IT), Projekt - Berichtswesen
Ausbildung
Medical Mountains
EOQ
Dr. Johner Institut
PTS
EOQ
EOQ
EOQ
EOQ
Über mich
Machining- & Refinement- Processes as polishing, passivation, coating, cleaning
Laser Technology – Plastic Injection Moulding – Automated Assembling
Design & Development of Soft- and Hardware in integrated Systems
Design-Control – External- & Internal Audits – CAPA-/8-D-Management
Supplier-Management & -Evaluation – QA-Lead
Weitere Kenntnisse
Printed Circuit Bords (PCB) – Drug delivery systems - Catheters - Stents
IVD Liquid-Handlers – Cleanroom – IQ/OQ/PQ – CE-marking
Project Management
Supply Chain Operations
Complaint-, CAPA/ 8-D-Management
Regulatory, internal-/ external Auditing
Product Development, Design Control
Quality- & Risk-Management
Quality Assurance & Production
Verification, Validation, Qualification
Quality Engineering, Remediation
Vigilance, Post Market Operations
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Französisch (Fließend)
- Europäische Union
- Schweiz
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