QSR Auditor I

Conduct QMS audits on vendors, write reports, and follow up on supplier CAPAs. Lead vendor FDA projects by supervising the establishment of quality management systems under 21 CFR 820, managing onsite audits, and providing professional suggestions. Monitor vendor quality systems through regular visits to identify problems and provide necessary training. Support supplier FDA registration by guiding information collection and completing medical device listings. Complete assigned RA cases such as design control and process validations within timelines.