Change Control Manager (m/f/d)

Contract duration: 12 months

Location: Rotkreuz

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 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)

Must Haves:

• B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• Fluent German and English
• Min. 1-2 years of 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