Spec QA Sterilization
Medline Industries, LP · Wuhan, Hubei, China
Medical Equipment Manufacturing · 10,001+ employees
About the role
Review sterilization documentation and release products based on acceptance criteria and agreements. Manage sterilization databases, supervise sterilizer performance, and handle SCAR, deviation, and CAPA reports.
What they look for
Requirements
The candidate must be able to independently manage supplier-related sterilization issues and support validation activities. Experience in compliance and quality assurance within a sterilization context is required.
Benefits
Full description
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 page here.
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.
