Patrick Kolkena
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Patrick Kolkena
- Current 7 years, since Jun 2019HEINE Optotechnik GmbH & Co. KG
Manager Quality Management / Complaint
- 1 year and 9 months, Sep 2017 - May 2019
Quality Manager
sana-one GmbH
- 3 months, Jul 2017 - Sep 2017
Elternzeit
Familie - Elternzeit
- 2 years and 5 months, Feb 2015 - Jun 2017
Manager Quality and Regulatory Affairs D/A/CH
CareFusion Germany 318 GmbH (now part of Becton Dickinson)
- Customer complaints management - Vigilance reporting - Field safety corrective actions and implementation - Product approvals - Submissions and registrations - Documentation control - Product and service promotion documentation - Environmental data reporting - Quality system procedures includig eClass
- 3 years and 9 months, May 2011 - Jan 2015
Quality Management & Regulatory Affairs Coordinator
Medi-Globe GmbH
Registration of medical devices International, e.g. China, Japan, USA, Mexico, Sudan, Egypt (Regulatory Affairs Specialist); Maintaining and improvement of the Quality Management according ISO 13485 (ISO 9001); Complaint Handling International; Technical Documentation Specialist / Document Management (Xeri)
- 4 years and 3 months, Feb 2007 - Apr 2011
Technical Clerk Research & Development / Technical Documentation
Medi-Globe GmbH
Responsibility for organization / coordination of the Technical documentation Support of Project Engineers throughout all development stages in accordance with ISO 13485. Support of the Project Manager implementing and maintaining a Quality management system according to ISO 13485 and all requirements.
- 2 years and 5 months, Sep 2004 - Jan 2007
Trainee - Industrial Business Management Assistant
Medi-Globe GmbH
Vocational training as Industrial Business Management Assistant
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C2 (Verhandlungssicher / Muttersprachlich)
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