# Change Control Manager # (m/f/d) Freelance for a Project in Part-Time Capacity Start date: asap Reference number: 861725/1

# Change Control Manager # (m/f/d) Freiberuflich für ein Projekt in Teilauslastung Zug Start date: asap Reference number: 861725/1 ### Responsibilities ### * Managing change execution and change Coordination in the area of Global External Manufacturing with internal stakeholders (e.g. Quality Management) and external contract manufacturers * Responsible for the efficient implementation of changes within the company and also at the the contract manufacturer * Responsible for compliance application of the change and the corresponding KPIs * Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change * Notification, Design Master Record, Design History File etc * Planning and implementation of projects and work packages from product care projects with minimal supervision * Being a proactive member of the squad * Identification of process improvements in the working area (e.g. change process) ### Profile ### * B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise * Initial Project management experience * Work experience in change management or in project and process management * Practical experience in a regulated GxP environment, ideally in medical devices/IVD industry (ISO 13485, FDA 21 CFR 820, IVDR/MDR) * First professional experience in document management within a regulated environment * Good knowledge in SAP or comparable ERP system * Very good user skills in MS Office and Google applications * Very good communication skills in German (B1) and English (C1) (spoken and written) are required * Team player, independent and reliable way of working is expected ### Benefits ### * Fascinating, innovative environment in an international atmosphere * A very renowned company