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Quality Assurance Manager

Quality Assurance Manager

ProclinicalBasel, Schweiz
Vor 30+ Tagen
Stellenbeschreibung

Proclinical is seeking a Quality Assurance Manager to join our client's team in Basel, Switzerland. This role focuses on ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry. You will play a key role in quality management, supporting both local and global processes, and leading audits and quality-related projects.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities :

  • Review and approve content related to change control, nonconformities, and various project, product, and process documents.
  • Support and enhance local and global processes to align with regulatory standards.
  • Coach team members to develop skills and expertise for future business needs.
  • Lead preparation, implementation, and follow-up of internal and external audits.
  • Oversee quality aspects of design or technical product transfer projects to ensure compliance.
  • Lead or support global quality management or operations projects and act as a process consultant within the QMS.

Key Skills and Requirements :

  • Degree in technology or science, or equivalent professional experience in a technical field.
  • Experience in quality management of medical devices / IVDs, particularly with ISO 13485.
  • Ability to make independent decisions and develop solutions outside the comfort zone.
  • Strong communication skills in German and English, suitable for complex environments.
  • Project management experience.
  • Familiarity with agile working methods and challenging conventional thought patterns.
  • Audit experience and a strong understanding of QMS.
  • Excellent interpersonal skills to contribute to team cohesion and development.