Change Control Manager

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.