Quality Engineer

Katalyst CRO is seeking a Quality Engineer to support complaint investigations and quality system activities in a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, and ensuring compliance with FDA and GMP standards. Responsibilities Review customer complaints and associated service data to determine risk levels and identify problem/cause codesConduct complaint investigations and perform detailed root cause analysisAnalyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issuesPrepare investigation summaries, reports, and recommendations based on analysisReview existing investigation reports and identify GMP compliance gapsSupport development and implementation of corrective and preventive actions (CAPA)Drive continuous improvement initiatives and process control activitiesConduct data analysis using statistic