Complaints Handler

QA Complaint Intake Specialist / QA Complaint Triage AssociateLocation: San Diego, CA, 92121Duration: 06+ MonthsWe are seeking a detail-oriented QA professional with experience in medical device or pharmaceutical complaint handling, regulated documentation, and quality systems support.Key Responsibilities:• Intake, triage, and documentation of medical device complaints• Review and maintain complaint records within eQMS systems• Coordinate follow-up activities and collect missing investigation details• Support DHR review, lot/serial verification, and returned product tracking• Escalate serious/reportable events to QA leadership and investigators• Ensure compliance with FDA, ISO 13485, EU MDR, and internal proceduresRequired Skills:• Experience in complaint handling, QA, post-market surveillance, or regulated documentation• Knowledge of medical device/pharma quality systems and complaint workflows• Hands-on experience with eQMS systems preferred• Strong documentation, communication, and follow-up coordination skills• Ability to manage multiple records within regulatory timelinesPreferred Background:• Medical device or pharmaceutical industry experience• Exposure to FDA, ISO 13485, MDR, CAPA, or complaint investigation processes• BS/BA in scientific, healthcare, technical, or quality-related discipline preferred

Created: 2026-05-13