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

Company Overview

Hamilton Medical AG has been committed to the vision of driving innovation to improve people's lives since 1950. As an innovative pioneer, we provide advanced solutions in the health sector, specializing in ventilators, automated pipetting, sample management, and process sensor development. Our intelligent ventilators are designed for various applications and environments, including ICUs and emergency transport.

Your Impact

The microbiological quality control aspect is vital to ensuring effective hygiene monitoring in production areas and medical devices for user safety. This role involves contributing to the quality, regulatory, and vigilance department through active engagement in microbiological practices.

Key Responsibilities

• Serve as Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection during new product introduction and throughout the product lifecycle.
• Oversee compliance with cleanliness in design control and manufacturing processes in accordance with applicable standards.
• Generate and review technical hygiene requirements as part of the device technical file, ensuring accuracy and adherence to standards and regulations.
• Conduct processing and reprocessing assessments, protocols, and validations to provide instruction on cleaning, disinfection, and sterilization.
• Collaborate with hygiene quality and process engineers to drive improvements enhancing product and production hygiene.
• Review and update procedures related to production hygiene for efficient operations and worker safety.
• Ensure monitoring contributes to product safety from chemical and biological perspectives.

Required 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 in medical device manufacturing, particularly in relation to cleanliness standards, including ISO 13485 and AAMI guidelines.
• Fluent in both German (C1) and English (C1).
• Understanding of Good Practice (GxP) and classical microbiology fundamentals.
• Experience in an analytical laboratory is an advantage.
• Experience with biocompatibility according to ISO 10993 and/or in sterile packaging or cleaning and disinfection validations of active medical devices is advantageous.
• Willingness to travel up to 10% for supplier quality management and collaboration with affiliated companies.

Work Environment

At Hamilton, we cultivate a cooperative and straightforward atmosphere. We emphasize a motivating working environment complemented by leisure activities and modern work conditions. Open communication and respect for team contributions are at our core, fostering innovation and collaboration.

Explore Your Future

Discover career opportunities with Hamilton by visiting our website. Join a team that values your skills and encourages your innovative ideas!