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Cleanliness & Sterilization Manager, Kloten Client: Envista
Location:
Job Category: Other
Job Reference: 54a4d79e61bf
Job Views: 2
Posted: 17.04.2025
Expiry Date: 01.06.2025
Job Description: Job Description
Responsible for cleanliness & sterilization compliance of design control and manufacturing processes according to the applicable standards.
Act as SME for cleanliness, disinfection and sterilization in New Product Introduction and throughout the whole lifecycle of products
Generate and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring these documents are accurate and comply with applicable engineering-, medical device- and Nobel Biocare standards
Perform cleaning and sterilization validation and product reusability assessment in order to provide validated instructions for use regarding cleaning, disinfection and sterilization
Support cleanliness and sterilization Subject Matter Experts on the manufacturing sites to:
Drive improvements to enhance product cleanliness (cleanroom set-up, product final cleaning, tool cleaning etc)
Review and update procedures related to product cleanliness
Perform sterilization (re)validation
Perform in process monitoring related to product cleanliness and the sterilization.
Job Requirements: In-depth knowledge of Quality Management System regulations and the regulations, directives and standards related to microbiology, cleanroom, chemistry and process validation, in particular:
ISO 13485 (Quality Management System for Medical Devices)
ISO 11137-1 and ISO 11137-2
ISO 10993-1
AAMI TIR35
AAMI ST72
ISO 11737-1, ISO 11737-2 and ISO 11737-3
ISO 14644 series
Strong background in Chemistry, Biology, Biomedical or Microbiology.
5+ years of experience in the field of cleanliness & sterilization in the medical device or pharmaceutical industry
Good track record in leading cleanliness & sterilization teams, projects, specifying sterile medical device requirements and conducting cleanliness & sterilization validations leading projects in matrix organizations in the medical device or pharmaceutical industry, preferably in the dental industry.
Comprehensive experience of manufacturing process needs to meet cleanliness requirements.
Fluency in English is mandatory, other languages are welcome.
Operating Company: Nobel Biocare
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