Complaints Analyst

Position: Complaints Analyst – Medical DevicesLocation: Newark, DE (Onsite)Duration: 12 MonthsJob DescriptionNeed total of 9+ years of experience5+ years of experience in medical device industry with 3+ years in complaint handling and compliance investigations.Perform complaint triage, investigation, and closure activities for biopsy and mammography systems.Analyze mechanical and electrical component failures, troubleshoot issues, and perform root cause analysis.Review Nonconformance Reports (NCRs), complaint trends, and failure modes to identify recurring quality issues.Support CAPA activities, corrective actions, and product compliance investigations.Utilize TrackWise for complaint management, investigation documentation, and workflow tracking.Collaborate with manufacturing operators, engineering, field service, and quality teams to understand product functionality and process-related issues.Support FDA MDR evaluations and ensure compliance with FDA 21 CFR Part 820 and ISO 13485 requirements.Participate in complaint trending, risk analysis, and continuous improvement initiatives for electromechanical medical devices