Medical Device Quality Complaint Specialist

Cypress HCM in Irvine, CA is seeking a detail-oriented Complaint Handling Specialist to support and manage medical device complaint activities, including intake, documentation, triage, investigation, regulatory assessment, and closure in alignment with internal procedures, FDA 21 CFR 820, and ISO 13485.

You will log, track, and close complaints in the QMS, collaborate with cross-functional teams, and assist with MDR/vigilance reporting, audits, and continuous improvement efforts.