Senior Microbiologist Quality Control Specialist

vor 2 Monaten


DomatEms, Graubünden, Schweiz Hamilton Vollzeit
Join Our Team as a Senior Microbiologist Quality Control Specialist

We are seeking a highly motivated and experienced Senior Microbiologist Quality Control Specialist to join our Quality, Regulatory and Vigilance department at Hamilton. As a key member of our team, you will be responsible for ensuring the microbiological quality control of our medical devices and production areas.

Key Responsibilities:
  • Develop and implement microbiological quality control procedures and protocols to ensure compliance with ISO 14664, ISO 13485, and GMP.
  • Act as a subject matter expert (SME) for hygiene, cleanliness, and disinfection for new product introduction and throughout the product lifecycle.
  • Generate and review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements.
  • Perform processing and reprocessing assessments, protocols, and validations to provide validated instructions for use regarding cleaning, disinfection, and sterilization.
  • Support hygiene quality and process engineers on manufacturing sites to drive improvements to enhance product and production hygiene.
Requirements:
  • Master's or PhD in Microbiology or a closely related field.
  • Foundational knowledge and minimum 4-year experience in the application of processes according to established QMS procedures.
  • Medical device manufacturing experience from a cleanliness perspective, including ISO 13485, ISO 10993-1, AAMI TIR30,12, AAMI ST98, and ISO 14644 series.
  • Fluent in German (C1) and English (C1).
  • Understanding of Good Practice (GxP) and fundamentals of classical microbiology.

We offer a motivating working environment, various leisure activities, and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. If you share our values and are passionate about microbiology, apply now using the "Apply now" button. If you have any questions, please contact us at with the following details: Reference: JR-4307-fjm/Contact: Ilaria Cerullo. Applications by post or e-mail cannot be considered.



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