Quality Assurance Specialist
vor 2 Monaten
Job Summary:
We are seeking a highly skilled Cleanliness and Sterilization Manager to join our team at Envista. As a key member of our organization, you will be responsible for ensuring the cleanliness and sterilization of our design control and manufacturing processes meet the highest standards.
Key Responsibilities:
- Act as a Subject Matter Expert (SME) for cleanliness, disinfection, and sterilization in New Product Introduction and throughout the product lifecycle.
- Develop and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring accuracy and compliance with applicable standards.
- Perform cleaning and sterilization validation and product reusability assessments to provide validated instructions for use regarding cleaning, disinfection, and sterilization.
- Support cleanliness and sterilization SMEs on manufacturing sites to drive improvements, review and update procedures, and perform sterilization (re)validation.
- Conduct in-process monitoring related to product cleanliness and sterilization.
Requirements:
- Deep knowledge of Quality Management System regulations and regulations related to microbiology, cleanroom, chemistry, and process validation.
- Strong background in Chemistry, Biology, Biomedical, or Microbiology.
- 5+ years of experience in cleanliness and sterilization in the medical device or pharmaceutical industry.
- Proven track record of leading cleanliness and sterilization teams, projects, specifying sterile medical device requirements, and conducting cleanliness and sterilization validations.
- Comprehensive experience of manufacturing process needs to meet cleanliness requirements.
- Fluency in English is mandatory, other languages are welcome.
About Envista:
Envista is a leading company in the dental industry, committed to delivering high-quality products and services. We are dedicated to innovation, customer satisfaction, and employee development.
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