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Expert Global QMS(m/w/x)

Greiner Bio-One International GmbH
Kremsmünster, Wien, Frickenhausen

You manage the electronic document system and support the global quality management system, ensuring effective communication and leadership across various projects and teams.

Anforderungen

  • •Bachelor's degree in chemistry or engineering
  • •Knowledge of FDA 21 CFR 820 and ISO 13485
  • •Experience in global organizations
  • •Experience in quality management for medical devices
  • •Auditor training is a plus
  • •Project management skills are an advantage
  • •Very good English skills required

Deine Aufgaben

  • •Serve as System Owner for ConSense.
  • •Support global rollout of e-QMS modules.
  • •Review and approve global QM documents.
  • •Prepare and execute the Global Management Review.
  • •Act as global interface to local QM organizations.
  • •Lead global projects and indirect project teams.

Deine Vorteile

Exciting global position
Opportunity to shape quality systems
Numerous social benefits
Minimum annual salary based on group IV
Compensation based on local conditions

Original Beschreibung

## Your Challenge We are looking for a committed and structured quality professional to strengthen our global Quality Management team. In your role as Expert Global QMS at Greiner Bio-One International GmbH, you will be responsible for managing and further developing global quality management processes and systems. A key focus will be your role as System Owner and Global Key User for our electronic document management system (ConSense), as well as the global implementation of e-QMS modules such as CAPA and Complaint Handling. **Your main responsibilities include:** •    System Owner and Global Key User for the electronic document management system ConSense •    Global rollout and support of e-QMS modules (CAPA, Complaint Handling) •    Review and approval of global QM documents (e.g., QM processes, Quality Manual, etc.) •    Preparation and execution of the Global Management Review •    Acting as global interface to local QM organizations, business units, and operations •    Future lateral leadership of global projects and indirect project team members ## Your profile •    Completed education: HTL, Bachelor's degree or comparable qualification in chemistry, engineering, life sciences or related quality disciplines •    Experience in international QM organizations; knowledge of FDA 21 CFR 820 and ISO 13485 •    Experience in global organizations and matrix structures •    Experience in quality management in the field of medical devices or in vitro diagnostics (IVD) •    Auditor training is a plus •    Project management skills are an advantage •    Very good English skills required; other languages are an advantage Possible locations: Kremsmünster (AT), Vienna (AT), Frickenhausen (DE), Monroe (USA). Travel requirements are very low and limited to project-specific assignments; many tasks can be carried out remotely.
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