Specialist CAPA Management (m/f)

- Implementation of the standardized procedures, processes and systems for CAPA
- Training for CAPA users and assist with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination
- Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes
- Provide CAPA compliance metrics and weekly management tracking report
- Implement measures to monitor the effectiveness of the CAPA system, ensure results of verification and monitoring of the effectiveness of CAPA
- Facilitate Change Management activities resulting from the standardization of the CAPA process and associated systems
- Collaboration with EU CAPA Manager in establishing and implementing policies, procedures and quality objectives
- Identify opportunities for procedural harmonization and integration
- Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations, collaborate in the identification and implementation of corrective actions
- Working knowledge of Quality System Regulations and CAPA Management
- Excellent communication skills, to quickly build credibility within the Quality and Compliance community
- Fluent in German and in English
- Strong knowledge of quality and compliance for Medical Device Industry (GMPs)
- Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards

Weitere Qualifikationen: Quality manager