Patrick Kolkena

Berufserfahrung von Patrick Kolkena

• Bis heute 5 Jahre, seit Juni 2019

  Manager Quality Management / Complaint

  HEINE Optotechnik GmbH & Co. KG

• 1 Jahr und 9 Monate, Sep. 2017 - Mai 2019

  Quality Manager

  sana-one GmbH

• 3 Monate, Juli 2017 - Sep. 2017

  Elternzeit

  Familie - Elternzeit

• 2 Jahre und 5 Monate, Feb. 2015 - Juni 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 Jahre und 9 Monate, Mai 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 Jahre und 3 Monate, 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 Jahre und 5 Monate, Sep. 2004 - Jan. 2007

  Trainee - Industrial Business Management Assistant

  Medi-Globe GmbH

  Vocational training as Industrial Business Management Assistant