Microbiologist Quality Control 80 – 100

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

Compania Hamilton Medical AG

Domeniu de activitate Managementul Calității și Regulatory Affairs

Sediu Allschwil (Basel-Landschaft) (CH), Domat/Ems (CH)

Program Home Office Până la 20 %

Tipul contractului Angajat pe perioadă nedeterminată

Număr referință JR-4307

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 in the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.

How You Can Make a Difference
We are looking for…
….a highly motivated
Microbiologist Quality Control
for our
Quality, Regulatory and Vigilance
department.

The microbiological quality control is essential to ensure efficient and controlled monitoring of the hygiene in the production areas and on our medical devices to ensure end user safety. As a Senior Microbiologist in the Biocompatibility Team, you will be responsible for providing microbiological expertise in creating and implementing SOPs, and WIs to support our quality engineers in our production facilities in Domat/Ems, Graubünden for new product introduction, monitoring and/or deviations and CAPA's. You will support/lead task forces investigating cleaning and disinfection protocols and testing at external CRO's. Additionally, you will optimize analytical methods and production facility procedures and infrastructure (cleanrooms) as needed in accordance to ISO 14664, ISO 13485, and GMP.

• Act as SME for hygiene, cleanliness, and disinfection for new product introduction and throughout the product lifecycle
• Responsible for cleanliness compliance of design control and manufacturing processes according to the applicable standards
• Generate and review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements, ensuring these documents are accurate and comply with applicable engineering-, medical device- and internal and external standards, regulations, directives and guidelines
• Perform processing and reprocessing assessments, protocols and validations in order to provide validated instructions for use regarding cleaning, disinfection and sterilization, to internal and external stakeholders
• Support hygiene quality and process engineers and on the manufacturing sites to: – Drive improvements to enhance product and production hygiene (cleanroom set-up, semi-finished or finished goods cleaning, tool maintenance, traceability etc)
• Review and update procedures related to production hygiene to ensure efficient procedures ensuring worker and product safety
• Ensure process, tooling and product monitoring contributes to chemically and biologically safe product

That's What You Bring Along

• Master's or PhD in Microbiology or a closely related field
• Founded knowledge and minimum 4 year experience in the application of processes according to established QMS procedures

• Medical device manufacturing from a cleanliness perspective, in particular:

• ISO Quality Management System for Medical Devices)

• ISO
• 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 an advantage
• 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
• Expect to be travelling up to 10% to assist supplier quality in supplier management and/or affiliated companies locally and globally

Learn more about career opportunities at Hamilton at

Skills
Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button. If you have any questions, please contact us at with the following details:

Reference: JR-4307-fjm/Contact: Aileen Müller

Applications by post or e-mail can unfortunately not be considered.

Ce oferim

Staff discounts for many leisure activities and services
Green Sense: The healthy and sustainable staff restaurant
Sports & Fun – See What Surprises Lie In Store
Advisory services provided by external partners for various life situations
Diverse opportunities for further training and development
An informal working environment
Compensation time for bridging days between Christmas and New Year
A dedicated pension fund with the possibility to choose from three options
You can find more of our benefits and working conditions here

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