Quality Complaints Analyst

Job Title: Quality Complaints AnalystLocation: New YorkDuration: 12 MonthsJob Summary:We are seeking a Quality Complaints Analyst with experience in the medical device industry to support complaint handling, investigations, and post-market quality activities. The candidate will evaluate customer complaints, perform root cause investigations, support CAPA activities, and ensure compliance with FDA and ISO 13485 requirements.Key Responsibilities:Review and investigate product complaints in accordance with quality system procedures.Conduct root cause analysis using tools such as 5 Why, Fishbone, and 8D methodologies.Support CAPA, Non-Conformance, and Change Control activities.Perform complaint trending and data analysis to identify recurring quality issues.Collaborate with QA, Regulatory Affairs, Manufacturing, and Engineering teams.Maintain complaint records within eQMS and ensure timely closure.Support FDA inspections, internal audits, and regulatory compliance activities.Requirements:Bachelor's degree in Engineering, Life Sciences, Biology, or related field.3+ years of complaint handling, quality assurance, or quality engineering experience in the medical device industry.Knowledge of FDA 21 CFR Part 820, ISO 13485, CAPA, and complaint investigations.Strong analytical, documentation, and communication skills.Experience with TrackWise, MasterControl, SAP, or similar quality systems is preferred.