Job ID: 11900

Head of Quality Management



Ihre Aufgaben.

  • Assist project manager on development projects
  • Lead the Quality Management Department
  • Maintenance and development of the ISO 13485 und 93/42/EWG QM system, adjustment to FDA and GMP requirements
  • Execution on audits: Notified body, customers, legal authorities, FDA
  • Complaint handling system including CAPA
  • Execution of internal and supplier audits
  • Development of the risk management system • Analysis of production and quality data
  • Initiation and tracking of improvement projects
  • Support on validation activities for process methods and software
  • Execution of trainings, especially on QM relevant topic
  • Contribution to further development of Brunie (ERP-System)

  • Experience in managing and leading complex tasks and projects with the ability to plan, manage and execute
  • Experienced Auditor having worked closely with/for a notified body
  • Third Level Education (Level 9) in related discipline
  • Be a well-organized, detail-oriented individual who can multi-task and self-manage in an open space work environment. Also be able to handle and manage constant work-related interruptions
  • Be a self-starter with the ability to influence others quickly and positively. Making an instant impact in developing a team

Ihr Anforderungsprofil.

  • 0-2 years of experience in medical device development
  • 5+ Years Experience in a senior quality position with experience of above roles especially in the medical device sector
  • Third Level Education (Level 8) in quality or related discipline
  • Robust ISO 13485, ISO 14971, QSR (FDA) knowledge
  • Business fluent in English and German
  • Experience in internal and supplier audits as well as statistical methods
  • The ability to create and manage great relationships internally having to work cross functionally but also externally, especially with FDA and other agencies


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