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Sterilization Spec - NPS Waukegan, IL
Waukegan, IL
Job Description
JOB SUMMARY:Provide quality assurance and technical ethylene oxide sterilization support to the terminal sterilization of medical devices and other healthcare products. The position will support the Medline Product Divisions and external customers in order to maintain compliance to regulations and industry standards. MAJOR RESPONSIBILITIES: Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution. Maintain sterilization files and document libraries. Create and update NPS procedures, Quality System Forms, Specifications and other controlled documents including sterilization process parameters as needed for improvements to the process and to maintain compliance to industry and regulatory standards. Compile and analyze trending data related to process deficiencies (deviations, complaints, damage) or for purposes of process improvements and maintaining process effectiveness. Prepare trending data for monthly and quarterly reports. Develop, schedule, and administer plant trainings and initiate corrective actions on a periodic and an as-needed basis to maintain regulatory compliance and to address process related issues. Respond to customers and conduct investigations related to Customer Complaints, CAPAs, Deviations, audit findings, and customer requests including aiding in implementation of any required actions for plant personnel. Monitor, track, and ensure proper closure of open complaints, CAPAs, and deviations. Assist in hosting internal and external audits including customers and regulatory bodies. Represent the facility on matters pertinent to the Quality Management System as established through regulations, industry standards and procedures. Assist audit team in vendor audits as needed for technical support. Review various facility processing and maintenance documentation including process logs, equipment maintenance, equipment qualifications, and calibration records for acceptability and to ensure compliance to regulatory standards. Prepare protocols for customer sterilization validations. Work with customers on the development and maintenance of sterilization parameters specific to their products. Review test results, run records, analyze temperature and humidity data to ensure they meet the acceptance criteria of the protocol and prepare applicable final reports for customer approval. Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete multiple simultaneous EO validation activities or customer special requests with time sensitive schedules. Coordinate and assist in validation product load set up and sample/sensor retrievals. Configure, set-up, and download sensors used for various customer validation and equipment qualification studies. Review and ensure sensors meet calibration specifications prior to and after studies as defined in NPS procedures or customer protocols. Perform investigations for sensors that do not meet specification or fail during use.Education Bachelor's degree with a scientific or engineering background.Work Experience At least 2 years of experience supporting terminally sterilized medical products from a quality assurance and technical perspective.Knowledge / Skills / Abilities Strong understanding of ISO11135 and ISO13485 standards. Intermediate level skill in Microsoft Excel (for example: using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling). Intermediate level skill in Microsoft Word (for example: inserting headers, page breaks, page numbers and tables and/or adjusting table columns). Ability to lift up to 50lbs and be capable of periodic SCBA use. Ability to work safely in environments where hazardous chemicals may be encountered.PREFERRED JOB REQUIREMENTS Bachelor's Degree in Microbiology or Engineering. Member of Sterilization AAMI working groups. CISS-EO certified.
Job Summary
Company
Medline Industries
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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