CSV Requirements Engineer

Tasks What you can achieve: Together with the overall project manager and our internal customers, you determine the requirements and develop a structured system analysis. For the projects under your supervision, you are responsible for them in coordination within the CSV compliance team. You are in active exchange with our internal customers to resolve deviations from the definitions. Requirements What you bring: Strong sense of responsibility and quality awareness. University or technical college degree, preferably in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering or IT. Very good German and English skills. Professional experience in the Life Science sector, especially in the context of CSV activities (Computer System Validation). Further training in the field of quality management, e.g. ISO 13485, 21 CFR Part 820, IVDR or MDR, is an advantage. Structured and pragmatic way of working as well as the ability to analyze systems and develop requirements efficiently and in a solution-oriented manner. Languages Very good German and English skills