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Job Summary
Job Description
1. Perform QMS audit to vendors, write audit report, and follow-up supplier CAPA.
2. Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820, work with vendor to deal with FDA onsite audit, act as consultant to help vendor establish a better QMS with professional suggestions.
3. Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
4. Provide necessary QMS training to vendor.
5. Support on supplier FDA registration, independently guide supplier on registration information collection, compete the medical device listing timely.
6. Complete assigned RA case like design control, process validations within timeline under good cooperation with QAs and other stakeholders.
7. Support team on internal audit and CAPA follow up if needed.
Other tasks assigned by supervisor, like Kaizen projects, etc.
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.
