Microbiology - QC - Biocompatibility
Medical Devices - Protocols and Testing - 13’485Our customer is one of the leading companies in the areas of intensive care. More than half of the employees work at the headquarters for development and production in Switzerland. For the second time in a row, our customer received the Top Company award from the most important rating portal in German-speaking countries.
Our client is looking for a highly motivated person with a deep understanding of microbiology in connection with QC testings for medical device registration. and disinfection. You will support the Biocompatibility Team with your knowledge and input. As SME you will lead task forces investigating cleaning and disinfection protocols and testing at external CRO's.
Your Tasks
- Testing microbiology compliance for new product introductions
- Assure that CRO partner meets all the regulation and compliance standards
- Monitoring and supporting CAPA-Processes during the manufacturing process
- Manage and improve overall on-site product and production hygiene
- Writing and implementation from SOP’s
- Visiting suppliers locally and globally (10%) and support them on-site on quality compliance
- University degree in Microbiology or related
- 3-5 years of experience in QMS of medical devices/GxP
- Knowledge standards 13485, 10993-1, 14644
- Experience in an analytical laboratory is preferred
- Fluency in German and English
Interested? We are looking forward to get in touch with you.
