Change Control Manager

vor 4 Wochen


Rotkreuz, Schweiz Flexsis Vollzeit

**INTRODUCTION:
**Change Control Manager

General Information:
Start date: 01.02.2024

Latest Start Date: 01.04.2024

Planned duration: 1 year

Extension: likely

Workplace: Rotkreuz

Workload: 70-100%

Remote/Home Office: 2-3 days a week

Travel: less than 5%

**ASSIGNMENT DESCRIPTION:
**Tasks & 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 within the client and also at the the contract manufacturer
- Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change Notification, Design Master Record, Design History File etc
- Identification of process improvements in the working area (e.g. change process)

**REQUIRED PROFILE:
**Must Haves:

- 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 communication skills in German and English (spoken and written) are required



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