Cleanliness & Sterilization Manager

vor 1 Woche

Kloten, Zürich, Schweiz Nobel Biocare Vollzeit

Operating Company:
Nobel Biocare

Location:
Kloten,Zurich,CH

Date Posted:
May 28, 2024

Req Number:
R5019715

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.
LI-MK1

Job Requirements:

  • Indepth 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 TIR3
  • AAMI ST7
  • 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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