Microbiologist Quality Control (Male/Female)

About Hamilton Medical AG

True to the vision - "We drive innovation to improve people's lives" - Hamilton Medical AG has been delivering solutions for the health sector since 1950. As an innovative pioneer, we specialize in ventilators, automated pipetting, sample management, and the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators, providing solutions that cater to a variety of patient groups and applications. Our products are utilized in Intensive Care Units (ICUs), emergency rescue transport, and during MRI scans, demonstrating our commitment to enhancing patient care across diverse environments.

Your Impact

We are seeking a highly motivated **Microbiologist Quality Control** to join our **Quality, Regulatory and Vigilance** department. In this role, you will play a critical part in ensuring the efficient and controlled monitoring of hygiene in our production areas and on our medical devices, safeguarding end-user safety.

As a Senior Microbiologist in the Biocompatibility Team, you will provide microbiological expertise in creating and implementing Standard Operating Procedures (SOPs) and Work Instructions (WIs) to support our quality engineers in the Domat/Ems production facilities. Your responsibilities will include:

• Acting as a Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection during new product introductions and throughout the product lifecycle.
• Ensuring compliance with cleanliness standards in design control and manufacturing processes.
• Generating and reviewing technical hygiene requirements specifications for device technical files and supplier quality agreements.
• Conducting processing and reprocessing assessments and validations to provide validated cleaning, disinfection, and sterilization instructions for internal and external stakeholders.
• Driving improvements in product and production hygiene, including cleanroom setups and tool maintenance.
• Reviewing and updating procedures related to production hygiene to ensure effective practices for worker and product safety.
• Ensuring product monitoring meets chemical and biological safety standards.

Your Qualifications

• Master's or PhD in Microbiology or a closely related field.
• A minimum of 4 years of professional experience in quality management systems (QMS).
• Knowledge of medical device manufacturing from a cleanliness perspective, particularly with the following standards:
  • 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 preferred.
• 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.
• Willingness to travel up to 10% to assist with supplier quality management local and global.

Join Our Team

If you share our values and thrive in a collaborative and down-to-earth environment, Hamilton Medical offers a motivating workspace alongside various leisure activities and modern working conditions. Our commitment to open communication fosters a supportive work atmosphere where innovative ideas are encouraged.

Interested candidates are encouraged to apply online using the form below. Please note that only applications matching the job profile will be considered. For any inquiries, you may contact us at jobs@hamilton.ch with the following reference: JR-4307-fjm/Contact: Aileen Müller.

We regret to inform that applications submitted via post or email cannot be accepted.