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

Hamilton; Ems; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

Hamilton is seeking a Senior Microbiologist Quality Control to ensure hygiene in production and compliance with medical device standards. The role involves developing SOPs, leading investigations, and supporting quality engineers to optimize processes. Candidates should have a Master’s or PhD in Microbiology and relevant experience in quality management systems.

Qualifikationen

• At least 4 years of experience applying processes according to QMS procedures.
• Fluent in German (C1) and English (C1).
• Experience in analytical laboratories is advantageous.

Aufgaben

• Act as SME for hygiene, cleanliness, and disinfection throughout product lifecycle.
• Ensure compliance with ISO 13485 and GMP standards.
• Monitor processes to ensure chemical and biological safety of products.

Kenntnisse

Microbiological expertise

Knowledge of cleanliness standards

Understanding of GxP practices

Ausbildung

Master’s or PhD in Microbiology

Jobbeschreibung

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 pioneers in ventilators, automated pipetting, sample management, and process sensors. Hamilton Medical is a leading manufacturer of intelligent ventilators, serving ICU, emergency transport, and MRI scan environments.

How you can make a difference:

We are looking for:

• a highly motivated Senior Microbiologist Quality Control for our Quality, Regulatory, and Vigilance department.

The microbiological quality control is vital to monitor hygiene in production areas and on our medical devices, ensuring end-user safety. As a Senior Microbiologist in the Biocompatibility Team, you will provide microbiological expertise, develop SOPs and WIs, and support quality engineers at our Domat/Ems facilities for new products, monitoring, deviations, and CAPAs. You will lead investigations into cleaning and disinfection protocols, optimize analytical methods, and ensure compliance with ISO 14664, ISO 13485, and GMP standards.

You will:

• Act as SME for hygiene, cleanliness, and disinfection throughout product lifecycle.
• Ensure design control and manufacturing process compliance regarding cleanliness standards.
• Generate and review hygiene specifications for device technical files and supplier agreements.
• Perform assessments, protocols, and validations for cleaning, disinfection, and sterilization processes.
• Support process engineers to improve product and production hygiene.
• Review and update hygiene procedures for efficiency and safety.
• Monitor processes to ensure chemical and biological safety of products.

What you bring along:

• Master’s or PhD in Microbiology or a related field.
• At least 4 years of experience applying processes according to QMS procedures.
• Knowledge of medical device manufacturing from a cleanliness perspective, including standards like 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 classical microbiology fundamentals.

Advantageous:

• Experience in analytical laboratories.
• Experience in biocompatibility, sterile packaging, reprocessing, cleaning, and disinfection validations of active medical devices.

Travel up to 10% for supplier management and global support.

Learn more about career opportunities at Hamilton.

If you share our values and thrive in a cooperative environment, apply online using the "Apply now" button. For questions, contact us at [contact details]. Applications by post or email are not accepted.