Duration: 12 months
Location: Rotkreuz
Workload: 100%
Home office: yes, 1-3 days a week
Responsibilities:
* Managing change execution and change Coordination in the area of Global Operations Consumables with internal stakeholders (e.g. Quality Management) and external contract manufacturers
* Responsible for the efficient implementation of changes 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 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)
Requirements:
* B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
* 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 and English (spoken and written) are required
* Team player, independent and reliable way of working is expected.
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