True to the vision "We drive innovation to improve people''s lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sle management and in the development of process sensors.
Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan our solutions cover a multitude of patient groups, applications and environments.
How you can make a difference :
We are looking for...
....a highly motivated Senior Microbiologist Quality Control for our Quality, Regulatory and Vigilance department.
The microbiological quality control is essential to ensure efficient and controlled monitoring of the hygiene in the production areas and on our medical devices to ensure end user safety. As a Senior Microbiologist in the Biocompatibility Team, you will be responsible for providing microbiological expertise in creating and implementing SOPs, and WIs to support our quality engineers in our production facilities in Domat/Ems, Graubunden for new product introduction, monitoring and/or deviations and CAPA''s. You will support/lead task forces investigating cleaning and disinfection protocols and testing at external CRO''s. Additionally, you will optimize analytical methods and production facility procedures and infrastructure (cleanrooms) as needed in accordance to ISO 14664, ISO 13485, and GMP.
* Act as SME for hygiene, cleanliness, and disinfection for new product introduction and throughout the product lifecycle
* Responsible for cleanliness compliance of design control and manufacturing processes according to the applicable standards
* Generate and review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements, ensuring these documents are accurate and comply with applicable engineering, medical device and internal and external standards, regulations, directives and guidelines
* Perform processing and reprocessing assessments, protocols and validations in order to provide validated instructions for use regarding cleaning, disinfection and sterilization, to internal and external stakeholders
* Support hygiene quality and process engineers and on the manufacturing sites to: Drive improvements to enhance product and production hygiene (cleanroom set up, semi finished or finished goods cleaning, tool maintenance, traceability etc)
* Review and update procedures related to production hygiene to ensure efficient procedures ensuring worker and product safety
* Ensure process, tooling and product monitoring contributes to chemically and biologically safe product