Cleanliness & Sterilization Manager

Job Description

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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.

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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 Quality Management System for Medical Devices) ISO and ISO ISO AAMI TIR35 AAMI ST72 ISO , ISO and ISO 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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