Control Manager; m​/w​/d

Stellenbeschreibung

Are you an experienced Change Control Manager looking for your next challenge in a fast‑paced, regulated environment? Join a global leader in diagnostics and medical technology, where innovation meets excellence in external manufacturing. This role offers a unique opportunity to drive change management, ensure regulatory compliance, and collaborate with cross‑functional teams to optimize global operations.

Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

The perfect candidate is someone who has knowledge and experience in GMP regulations and practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and process thinking.

• 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 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)

• B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• 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
• 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

• Start date:
  
  asap
• latest
  
  Start Date:
  
  1.06.2026
• Planned duration: 12 months
• Extension: possible
• Workplace:
  Rotkreuz
• Workload: 70-100%
• Remote/Home Office: 2-3 days a week On-site
• Team: ca. 10 people
• Department:
  Chapter Product Leadership
• Working hours:
  
  Standard