Quality Engineering
- Design control documentation
- Implementation of quality training
- Creation of FMEAs & risk analyses
- Assistance in creation of design history files
Medical/Clinical Affairs
- Scientific expertise
- Management of workshops & advisory boards
- Creation of design requirements from customer requirements
- Strategic research and evaluation of (bio)medical literature
- 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
- Knowledge TÜV certified
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 Management
- Analysis of the current and future demand for spaces and infrastructures
- Creating requirement matrices
- Managing the entire Management Of Change (MOC)
- Detailed layout or facility planning
- Planning of construction or relocation phases, even during ongoing operations
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
- Knowledge TÜV certified
Packaging
No Content
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)
- Administrative support in the following areas (including in international groups):
- Procurement
- Travel organisation
- Event organisation