Medical Device Sterilization Specialist

Chicago, IL

Job ID: 129693 Industry: Med


Medical Device Sterilization Specialist


Our client is a large medical device manufacturer. They are in need of a Sterilization Specialist with a background in Ethylene Oxide Sterilization. Providing regulatory and compliance direction to the companies suppliers.

Duties/Responsibilities/Scope of Work

•           Establishing and directing corrective actions and product disposition as it pertains to sterilization deviations and sterilization related product quality issues.

•           Establishing and directing corrective actions and product disposition as it pertains to cleaning and disinfection deviations and related product quality issues

•           Providing sterility assurance and biocompatibility clearance resource support for the administration of sterilization supply chain qualification / maintenance, product design control qualification as well as R&D product development/ new product launch.

•           Providing manufacturing site related external audit (i.e. FDA, TUV, BSI etc.) support as it pertains to sterilization qualification/maintenance, sterile product release and biocompatibility clearance.

•           Applying state of the art techniques to create a compliant, efficient, and cost-effective sterilization supply chain.

•           Qualifying reusable device related sterilization and cleaning processes that comply with FDA requirements and customer requirements/capabilities.

•           Identifying, qualifying, and managing contract sterilization as well as biocompatibility clearance and sterilization related contract laboratory test suppliers.

•           Designing and implementing sterilization related quality systems which comply with corporate policies and applicable external standards.

•           Establishing quality system documentation required for the qualification/implementation and maintenance of sterilization processes, sterile product release, and biocompatibility clearance as they pertain to compliance per applicable external standards/regulations.

•           Developing, validating, and implementing new / state-of-the-art test methods to support sterility assurance, cleaning-disinfection, and biocompatibility clearance programs.

•           Provide support to external suppliers on establishment and maintenance of qualified sterility programs and processes.

Required Experience:
  • Medical Device 
  • Ethylene Oxide Sterilization (known as EtO Sterilization or EO Sterilization)
  • Sterilization Validation
  • Writing Sterilization Testing Rationale

Job Type: Contract  

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