- Local and International auditing of suppliers (system, process and product).
- Identification, planning, implementation and coordination of development and validation activities, continuous improvement and manufacturing transfer projects
- CAPA''s and continuous improvement in supplier performance.
- Preparation, review and approval of validation documentation and monitoring progress of validation from suppliers.
- Definition of efficient and effective manufacturing processes and the associated testing strategies in consultation with Advanced Procurement and Quality.
Qualifications and experience
- A college / university / ETH degree in mechanical engineering, medical and manufacturing technology or similar
- Several years experience in quality management preferably within the Medical Devices sector (ISO 13485, QSR), but applications from professionals in the Pharmaceutical, Automotive or Auerospace industries will also be considered.
- Familiarity at least with the use of Six Sigma, Kaizen or 5S.
- Similarly, a basic knowledge &/or experience in clean room technology, sterilization procedures, chemical and biological test methods, process, and computer validations and test methods are a bonus.
- Good MS Office skills (Word and Excel) and excellent knowledge of English and German are mandatory as Suppliers are located throughout Europe. Travel of 30 - 40% is anticipated.
For more information on this vacancy, and also Supplier Quality roles in the UK/Europe in the medical devices sector, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at a.boroky@nonstop-devices.