We are looking for a Quality Management Employee to develop and improve our quality management system, plan and coordinate customer and regulatory audits, and manage the change management process.
Requirements
- Successful completion of a degree in the field of Natural Sciences, Medical Technology, Quality Management or a comparable qualification
- First professional experience in quality management, ideally in the regulated field (e.g. Medical Technology, In-Vitro-Diagnostics or Pharmaceuticals)
- Fundamental regulatory knowledge, particularly in the field of IVDR, ISO 9001 and ISO 13485, and experience in communication with regulatory bodies
- Experience in preparing, conducting and following up audits (internal/external)
- Knowledge in CAPA processes, Change Management and working with document management systems
- Analytical thinking, structured work method and high attention to detail
- Team skills and communication strength in exchange with internal interfaces and external partners
- Safe handling of digital tools and reporting systems, in particular Power BI, SAP Analytics and other common programs for data analysis