QSR Auditor I

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.