Cleanliness and Sterilization Specialist

Vor 5 Tagen


Stäfa, Zürich, Schweiz TN Switzerland Vollzeit

Company Overview:

TN Switzerland is a leading provider of medical devices, seeking an experienced professional to join our team as Cleanliness & Sterilization Manager. In this role, you will be responsible for ensuring the cleanliness and sterilization compliance of our design control and manufacturing processes according to applicable standards.

About the Job:

This is an exciting opportunity for a skilled professional to lead our cleanliness and sterilization efforts, ensuring that our products meet the highest standards of quality and safety. As Cleanliness & Sterilization Manager, you will be responsible for generating and reviewing technical specifications, performing validation and product reusability assessments, and supporting Subject Matter Experts on our manufacturing sites.

Key Responsibilities:

  1. Cleanliness and Sterilization Compliance: Ensure that our design control and manufacturing processes comply with applicable standards, including ISO 13485, ISO 11137-1, and ISO 10993-1.
  2. Technical Specifications: Generate and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring accuracy and compliance with applicable standards.
  3. Validation and Product Reusability Assessments: Perform cleaning and sterilization validation and product reusability assessments to provide validated instructions for use regarding cleaning, disinfection, and sterilization.
  4. Subject Matter Expert Support: Support cleanliness and sterilization Subject Matter Experts on our manufacturing sites in driving improvements to enhance product cleanliness, reviewing and updating procedures related to product cleanliness, performing sterilization (re)validation, and performing in-process monitoring related to product cleanliness and sterilization.


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