Microbiologist Quality Control 80 - 100 % (f/m/d)

Company Overview

At Hamilton Medical AG, our vision is to drive innovation to improve people’s lives. Since 1950, we have been at the forefront of providing solutions for the health sector, establishing ourselves as pioneers in ventilators, automated pipetting, sample management, and process sensor development. Our commitment to excellence makes us a leading manufacturer of intelligent ventilators, suitable for a wide range of patient groups and applications, including ICUs and emergency rescue transport.

Key Responsibilities

Joining our Quality, Regulatory, and Vigilance department, you will play a critical role in our microbiological quality control efforts, ensuring effective monitoring of hygiene in production areas and on medical devices, thereby safeguarding end-user safety. As a Senior Microbiologist within the Biocompatibility Team, your responsibilities will include:

• Acting as a Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection throughout product lifecycles.
• Ensuring cleanliness compliance of design control and manufacturing processes per applicable standards.
• Generating and reviewing technical hygiene requirements specifications to align with engineering, medical device, and regulatory standards.
• Performing processing and reprocessing assessments, creating validated cleaning, disinfection, and sterilization instructions for stakeholders.
• Supporting hygiene quality and process engineers to drive improvements in product and production hygiene.
• Reviewing and updating production hygiene procedures to enhance worker and product safety.
• Monitoring processes, tooling, and products to ensure chemical and biological safety.

Your Qualifications

• Master’s or PhD in Microbiology or a closely related field.
• A minimum of 4 years of experience applying processes according to established Quality Management System (QMS) procedures.
• Experience with medical device manufacturing focusing on cleanliness, particularly with ISO 13485, ISO 10993-1, AAMI TIR30,12, AAMI ST98, and ISO 14644 series.
• Fluency in German (C1) and English (C1).
• Strong understanding of Good Practice (GxP) and classical microbiology fundamentals.
• Experience in an analytical laboratory is an asset.
• Knowledge of biocompatibility standards, sterile packaging, and cleaning and disinfection validations of active medical devices is advantageous.
• Willingness to travel up to 10% to assist in supplier management locally and globally.

Work Environment

At Hamilton, we foster a cooperative and down-to-earth atmosphere where your abilities are recognized, and innovative ideas are encouraged. We offer a motivating work environment complemented by various leisure activities and modern working conditions. Our culture promotes open communication and collaboration at all levels.

Explore Your Future

If you are interested in advancing your career in a company that values innovation and quality, we invite you to learn more about opportunities within our organization. Together, let’s make a lasting impact on the health sector.