Quality Engineering
- Design control documentation
- Implementation of quality training
- Creation of FMEAs & risk analyses
- Assistance in creation of design history files
Medical Affairs
- Scientific expertise
- Management of workshops & advisory boards
- Creation of design requirements from customer requirements
- Literature research
- Investigation of national & international standards
Research & Development
- Process development
- Product development
- Innovation methods
- Material testing
- Prototyping
- Test planning
- Electronics development
- Laboratory support & management
- Verification & validation
- Statistical analysis
- Support in the creation of design requirement matrices
Regulatory Affairs
- Regulatory advice
- Preparation of technical documentation
- Preparation and submission of regulatory documents in accordance with MDR and FDA
- Knowledge about respective topics TÜV certified
Project Management
- International project & program management
- Product & project documentation
- Life cycle management
- Management and coordination of teams
- International communication
Quality Systems/Quality Operations
No Content
Facility
No Content
Process validation
- Basics of process validation
- Validation planning
- Risk-based sampling plans based on RQL and AQL
- Documentation practices
- Change control and monitoring of validated processes
- Validation reports
Other
- Learning management & training tools
- Newsletter & marketing material
- All-round back office work
- Strategy & team development
- Coaching
- Leadership Coaching by our external partner Ilka Fallgatter
- Management and coordination of teams
- Processing of databases (digitisation)