Join Us in Shaping the Future of Healthcare
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, offering solutions that cater to diverse patient groups and applications in various environments, including ICUs, emergency rescue transport, and MRI scans.
Your Impact as a Senior Microbiologist in Quality Control
We are seeking a highly motivated Senior Microbiologist to join our Quality, Regulatory, and Vigilance department. Microbiological quality control is vital to ensure efficient and controlled monitoring of hygiene in our production areas and medical devices, guaranteeing the safety of end users.
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 production facilities.
- Support or lead task forces investigating cleaning and disinfection protocols, as well as testing at external Contract Research Organizations (CROs).
- Optimize analytical methods and production facility procedures in line with ISO 14664, ISO 13485, and GMP standards.
Your Key Responsibilities
- Act as a Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection during new product introductions and throughout the product lifecycle.
- Ensure compliance with cleanliness standards in design control and manufacturing processes.
- Generate and review technical hygiene requirements as part of device technical files and supplier quality agreements.
- Conduct processing assessments, validations, and develop validated cleaning, disinfection, and sterilization instructions for stakeholders.
- Collaborate with hygiene quality and process engineers to enhance product and production hygiene.
- Review and update hygiene-related procedures for efficient and safe worker and product handling.
- Ensure process and product monitoring contributes to the safety of chemically and biologically safe products.
What You Bring
- A Master's or PhD in Microbiology or a closely related field.
- A minimum of 4 years of experience with Quality Management System (QMS) processes.
- Knowledge of medical device manufacturing standards (ISO 13485, ISO 10993-1, AAMI TIR30, AAMI ST98, ISO 14644 series).
- Fluency in German (C1) and English (C1).
- Understanding of Good Practice (GxP) principles and classical microbiology fundamentals.
- Experience in an analytical laboratory is advantageous.
- Familiarity with biocompatibility standards (ISO 10993) and sterile packaging is a plus.
- Willingness to travel up to 10% for supplier management and collaboration with global affiliates.
Why Hamilton?
At Hamilton, we offer not only a motivating working environment but also various leisure activities and modern working conditions. Our commitment to open communication fosters a pleasant workplace where your skills are valued and innovative ideas are encouraged.
Apply online using the form below. Please note that only applications matching the job profile will be considered.