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 the development of process sensors. Hamilton Medical is a leading manufacturer of intelligent ventilators, covering a multitude of patient groups, applications, and environments, including ICUs, emergency rescue transport, and MRI scans.
How you can make a difference:
We are looking for...
* a highly motivated Microbiologist Quality Control for our Quality, Regulatory, and Vigilance department.
The microbiological quality control is essential to ensure efficient and controlled monitoring of hygiene in production areas and on our medical devices to ensure end-user safety. As a Senior Microbiologist in the Biocompatibility Team, you will provide microbiological expertise in creating and implementing SOPs and WIs to support our quality engineers at our production facilities in Domat / Ems, Graubünden, for new product introduction, monitoring, deviations, and CAPAs. You will support or lead task forces investigating cleaning and disinfection protocols and testing at external CROs. Additionally, you will optimize analytical methods and production facility procedures and infrastructure (cleanrooms) as needed, in accordance with ISO 14644, ISO 13485, and GMP.
Key responsibilities include:
* Act as SME for hygiene, cleanliness, and disinfection throughout the product lifecycle.
* Ensure cleanliness compliance of design control and manufacturing processes according to applicable standards.
* Generate and review technical hygiene requirements specifications for device technical files and supplier quality agreements, ensuring accuracy and compliance with standards, regulations, directives, and guidelines.
* Perform processing and reprocessing assessments, protocols, and validations to provide validated instructions for cleaning, disinfection, and sterilization.
* Support hygiene quality and process engineers on manufacturing sites to drive improvements in product and production hygiene, review and update procedures, and ensure safe and effective processes.
Qualifications:
* Master’s or PhD in Microbiology or a closely related field.
* Minimum 4 years of experience applying processes according to established QMS procedures.
* Experience in medical device manufacturing 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 GxP practices and fundamentals of classical microbiology.
Additional advantages include:
* Experience in an analytical laboratory.
* Experience in biocompatibility according to ISO 10993, sterile packaging, or reprocessing/cleaning/disinfection validations of active medical devices.
Travel up to 10% for supplier management and collaboration with affiliated companies globally.
Learn more about career opportunities at Hamilton.
Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we offer a motivating working environment, leisure activities, and modern working conditions. Our open communication encourages a pleasant working environment. Become part of a team where your skills are valued and your ideas are fostered. Interested? Apply online using the "Apply now" button. For questions, contact us at [contact details].
Reference: JR-4307-fjm / Contact: Aileen Müller
Applications by post or e-mail cannot be considered.
#J-18808-Ljbffr