Quality and Change Coordinator | Quality & Change Koordinator * Roche Mannheim

Job Summary

This role involves acting as a Quality and Change Coordinator, primarily supporting packaging material experts at Roche Diagnostics GmbH in Mannheim. The core responsibilities focus on enhancing the risk management structure for reagent containers. Day-to-day tasks include preparing and moderating workshops with various stakeholders to conduct Failure Mode and Effects Analysis (FMEA), ensuring the standardization and lifecycle maintenance of these FMEAs. The coordinator will also assist in drafting critical quality documentation, such as test instructions and test plans. Candidates must possess a degree in natural science or engineering, coupled with solid professional experience in quality pre-planning within a regulated environment. Crucial technical expertise includes comprehensive experience in plastics processing, particularly injection molding and extrusion blow molding, alongside proficiency in risk analysis tools like APIS (nth). Excellent organizational skills and fluency in German are mandatory, as most communication and documentation are in German.