QUALITY MANAGEMENT COORDINATOR (M/F/D) (IT Quality Assurance Coordinator)

YOUR TASKS

• You will take on strategic leadership in the further development of the DMS and training tools in close cooperation with IT, as well as the strategic support of the Key Users at the locations of the STRATEC Group
• You will control, evaluate, and validate new releases of these two software tools to ensure seamless compliance status
• You will provide specialist consulting to managers and process owners regarding document control within the systems
• You will coordinate regular exchange with the Key Users to ensure optimal use of the DMS and training software
• You will directly support the Corporate VP Quality Management & Regulatory Affairs on overarching quality and document management topics

YOUR PROFILE

• You have completed vocational training with experience in a regulated environment (medical technology, IVD, or pharma)
• You possess very good knowledge of EN ISO 13485, FDA GMP, as well as the IVD Regulation
• You have expertise in the establishment and validation (CSV) of DMS and training software tools
• You demonstrate very good written and spoken English skills as well as experience working in interdisciplinary teams
• You are characterized by strategic thinking, proactivity, and an independent, solution-oriented way of working

Supplementary information:

Requirements for the applicant:

Advanced knowledge: Quality audit, Quality management, FMEA (Failure Mode and Effects Analysis), GMP (Good Manufacturing Practice), Quality management methods/tools, Project management, Measurement methods (handling, determining, etc.), Ishikawa, Minimum standards for medical devices according to DIN EN ISO 13486, IT coordination, 5S method