Competencies & experiences
- Experienced project leader in the development, qualification and validation, optimization of tools (mould injection), machine-tool, equipments and facilities as well as manufacturing procedures for medical devises
- Highly qualified in the development, quality management and manufacturing of medical devices
- Responsible, trustful leader with hand-on mentality
- Reliable decision maker
- Manager with a creative and sustainable approach in solving problems
- Good knowledge in English and German
- Knowledge in Russian, Spanish and Chinese (Mandarin)
- Years of experience in GMP confrom manufacturing areas
- Die casting / injection moulding of disposables and medical devices as a supplier
- Manufacturing, assambling of medical devices, implants and bulk products as a legal manufacture
- Cleaning of medical devices (implants and surgical instruments)
- Packaging of medical devices
- Combination products
- Many years of experience in quality management
- Organisation management
- Validation management
- Document control
- Risk management
- Deviation and complaint management
- Change management
- Supplier (rist &quality) management
- Audit management
- CAPA management
Professional career 1997-present
- Production and Process Engineer (Biotronik GmbH)
- Quality Engineer (Biotronik Schweiz AG)
- Technical Product Manager / Project Manager (Wilden Schweiz AG)
- Head of Production (Wilden Schweiz AG)
- Validation Specialist / Technical Product Manager (Gerresheimer Wilden AG)
- Head of Quality Management (Gerresheimer Wilden GmbH)
- Head of Quality Assurance (Bioptron AG)
- Operational Quality Manager (Ortek AG)
- Head of Qualification and Validation (Roche Diagnostics Ltd)
- Principal Consultant and Managing Director (Grosse-Schuette-Consulting GmbH) present