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Medline Industries, LP logo

Posted 2 months ago

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Spec QA Sterilization

WuhanRemoteFull-time

AI Summary

Reviews sterilization documentation and product release records against Medline's sterilization agreements, ensuring sterility acceptance criteria are met before releasing products. Tracks release data, issues trending reports, manages sterilizer training, and handles SCAR, deviation, and CAPA documentation for supplier sterilization issues.

About this role

Job Summary

Job Description

  • Review the sterilization documentations related to sterilized products received from sterilization facility against the latest sterilization agreement between Medline and the facility, and release the products for sterility purposes if all acceptance criteria for sterility release have been achieved.
  • Collect, track and analyze release data, issue trending report. Review and update sterilization related database.
  • Manage, supervise and train sterilizer for performance of sterilized product release, make sure in compliance based on procedure.
  • Issue, track and close SCAR, deviation/non-conformance reports independently for supplier related sterilized product release issues. Issue CAPA under supervision, and support CAPA’s tracking and closure.
  • Support validation activities as needed. Update and manage sterilization processing agreement
  • Other work assigned by line manager.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Skills

Acceptance Criteria EvaluationCAPADatabase ManagementDeviation ReportingNon-conformance InvestigationProcessing AgreementsSCAR ManagementSterility AssuranceSterilization ValidationSterilizer OperationSupplier QualityTrend Analysis

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