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For our client, a leading International MedTech company located in Chur, Switzerland, we are looking for a

Senior Microbiologist QC 80-100%

for the Quality, Regulatory and Vigilance department.

The microbiological QC is essential to ensure efficient and controlled monitoring of the hygiene in the production areas and on the medical devices to ensure end user safety. You will be responsible for providing microbiological expertise in creating and implementing SOPs, and WIs to support quality engineers in the production facilities 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 standards
  • Generate/review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements, ensure accuracy of documents and compliance with engineering-, medical device- and internal and external standards, regulations, directives and guidelines
  • Perform processing and reprocessing assessments, protocols and validations to provide validated IfUs 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

That’s what you bring along:

  • Master, PhD in Microbiology or similar field
  • Min. 4y 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, GxP
  • Fluent in German (C1) and English (C1)

Advantage:

  • Experience in an analytical laboratory, in biocompatibility according to ISO 10993 and/or in sterile packaging and/or reprocessing/cleaning and disinfection validations of active medical devices
  • Expect to be travelling up to 10% to assist supplier quality in supplier management and/or affiliated companies locally and globally

Interested? Contact me!

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