Senior Microbiologist Quality Control Job Opportunity
About the Role
We are seeking a highly motivated Senior Microbiologist to join our Quality, Regulatory and Vigilance department. As a key member of our team, you will be responsible for providing microbiological expertise in creating and implementing Standard Operating Procedures (SOPs) and Work Instructions (WIs) to support our quality engineers in production facilities.
Key Responsibilities
* Act as Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection protocols for new product introduction and throughout the product lifecycle.
* Responsible for ensuring cleanliness compliance of design control and manufacturing processes according to applicable standards.
* Generate and review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements.
* Perform processing and reprocessing assessments, protocols, and validations to provide validated instructions for use regarding cleaning, disinfection, and sterilization.
* Support hygiene quality and process engineers on manufacturing sites to drive improvements in product and production hygiene.
* Review and update procedures related to production hygiene to ensure efficient procedures ensuring worker and product safety.
Requirements
* Masters 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, particularly with ISO 13485, ISO 10993-1, AAMI TIR30,12, and ISO 14644 series.
* Fluent in German (C1) and English (C1).
* Understanding of Good Practice (GxP) and fundamentals of classical microbiology.
About Us
We offer a motivating working environment, various leisure activities, and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. We value your skills and foster innovative ideas.