Senior Microbiologist Quality Control 80

vor 20 Stunden

Neuenburg, Schweiz Hamilton Medical AG Vollzeit

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, sample 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, Graubünden 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.

Key Responsibilities:
  • 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.
That's what you bring along:
  • 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.
  • Expect to be travelling up to 10% to assist supplier quality in supplier management and/or affiliated companies locally and globally.

Learn more about career opportunities at Hamilton at jobs.hamilton.ch.

Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button.

If you have any questions, please contact us at jobs@hamilton.ch with the following details:

Reference: JR-4307-fjm/Contact: Ilaria Cerullo

Applications by post or e-mail can unfortunately not be considered.

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