Senior Complaint Investigator – Medical Device

Position Overview:The role focuses on conducting high-volume, end-to-end investigations of product complaints related to a women's health medical device. The investigator will work onsite within a manufacturing facility and be responsible for reviewing, documenting, testing, and closing complaint records in the quality system.Key Responsibilities:Investigate 10,000+ remediation and product complaint cases.Process approximately 30+ complaints per day.Perform root cause analysis and complaint documentation.Conduct hands-on functional testing of returned products or devices.Maintain investigation records within TrackWise and other QMS systems.Ensure compliance with medical device quality and regulatory requirements.Meet weekly productivity and quality metrics.Work closely with Quality Management and manufacturing teams.Required Qualifications:Bachelor's degree in a science or engineering discipline.5+ years of complaint investigation experience in the U.S.Medical device or pharmaceutical complaint handling experience.Experience managing high complaint volumes (30+ daily).Strong Quality Management System (QMS) experience.Remediation complaint investigation experience.Ability to work independently with minimal supervision.Preferred Qualifications:TrackWise experience.Prior experience in FDA-regulated environments.Strong technical writing and documentation skills.