Senior Microbiologist Quality Control Specialist
Vor 7 Tagen
Hamilton is a leading manufacturer of intelligent ventilators, and we are seeking a highly motivated Senior Microbiologist Quality Control Specialist to join 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.
- 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.
- 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.
Requirements for the position include:
- Master's or PhD in Microbiology or a closely related field.
- Founded knowledge and minimum 4 year experience in the application of processes according to established QMS procedures.
- Medical device manufacturing from a cleanliness perspective, in particular: ISO 13485 (Quality Management System for Medical Devices) ISO 10993-1 AAMI TIR30,12 AAMI ST98 ISO 14644 series.
- Fluent in German (C1) and English (C1).
- Understanding of Good Practice (GxP) and fundamentals of classical microbiology.
- Experience in an analytical laboratory is an advantage.
- Experience in biocompatibility according to ISO 10993 and/or in sterile packaging and/or reprocessing/cleaning and disinfection validations of active medical devices is an advantage.
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