CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.
For our client, a leading international MedTech company, we are looking for a:
Senior Microbiologist QC 80-100% (6306)
This permanent position is based in either Bonaduz or Allschwil and is part of the Quality, Regulatory, and Vigilance department.
Key Responsibilities:
* Act as a Subject Matter Expert (SME) for hygiene, cleanliness, and disinfection, supporting new product introductions and the entire product lifecycle.
* Ensure compliance with cleanliness standards in design control and manufacturing processes.
* Generate and review technical hygiene requirements specifications for device technical files and supplier quality agreements, ensuring compliance with engineering, medical device, and regulatory standards.
* Conduct processing and reprocessing assessments, protocols, and validations to provide validated Instructions for Use (IFUs) on cleaning, disinfection, and sterilization for internal and external stakeholders.
* Support hygiene quality and process engineers at manufacturing sites to drive improvements in product and production hygiene (e.g., cleanroom setup, semi-finished/finished goods cleaning, tool maintenance, traceability).
* Review and update production hygiene procedures to enhance worker and product safety.
* Ensure process, tooling, and product monitoring contribute to chemically and biologically safe products.
Requirements:
* Master’s or PhD in Microbiology or a related field.
* Minimum 4 years of experience in quality management processes under an established Quality Management System (QMS).
* Expertise in medical device manufacturing from a cleanliness perspective, with knowledge of:
* ISO 13485 (QMS for Medical Devices), ISO 10993-1, AAMI TIR30/12, AAMI ST98, ISO 14644 series, GxP.
* Fluent in German (C1) and English (C1).
Preferred Qualifications:
* Experience in an analytical laboratory or biocompatibility testing in accordance with ISO 10993.
* Knowledge of sterile packaging and/or reprocessing, cleaning, and disinfection validations for active medical devices.
* Willingness to travel up to 10% for supplier quality management and collaboration with affiliated companies, both locally and globally.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
Seniority level
Associate
Employment type
Full-time
Job function
Research, Science, and Manufacturing
Industries
Medical Equipment Manufacturing
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