Sterilization Assurance Specialist
2 weeks ago
Medline Industries is seeking a highly skilled Sterilization Assurance Specialist to lead advanced technical sterilization support for sterilization-related projects across various product divisions, facilities, and contract laboratories. This role is responsible for maintaining compliance with regulations and industry standards, such as 21 CFR Part 820, ISO11135, ISO11137, and ISO13485.
Key Responsibilities- Provide Expert Technical Support: Offer technical expertise for sterilization-related projects, including ethylene oxide, radiation, and steam processes, to ensure compliance with regulatory requirements.
- Develop and Implement Solutions: Develop responses to sterilization-related requests and audit findings, and provide technical support during audits of Medline facilities, sterile vendors, sterilization facilities, and contract laboratories.
- Participate in Industry Standards Development: Participate in technical committees, such as AAMI sterilization standards development, and actively contribute to reviewing proposed standards and submitting comments.
- Monitor Industry Practices and Develop Procedures: Monitor sterilization industry practices against internal processes and create or update procedures to maintain industry and regulatory compliance.
- Develop and Conduct Training: Develop sterilization training materials and conduct training for the sterilization department, quality team members, and divisional personnel.
- Analyze Data and Make Recommendations: Develop and review statistical analysis data and make recommendations for improvement, and establish implementation plans.
- Provide Technical Assistance and Decision-Making: Meet with divisional personnel to provide technical assistance and make decisions related to ethylene oxide, steam, and radiation sterilization processes.
- Education and Certification: Bachelor's degree with a scientific or engineering background and certification as a Certified Industrial Sterilization Specialist (CISS).
- Experience: At least 4 years of direct experience working in the industrial sterilization of healthcare products, including EO cycle development and validation, radiation dose setting, and moist heat experience.
- Regulatory Knowledge: Strong understanding of ISO 11135, ISO 11137, and ISO 17665, as well as microbiology principles related to terminal sterilization and chemistry principles related to EO/ECH residuals.
- Travel Requirements: Position requires travel up to 20% of the time for business purposes.
- Industry Expertise: Member of AAMI sterilization working groups/committees.
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