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CAPA Quality Engineers
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Entegee, Inc.
Murrysville, PA (In Person)
Full-Time
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Job Description
CAPA Engineer role focused on leading corrective and preventive action investigations, root cause analysis, quality data review, and CAPA documentation within a medical device environment. Job Requirements Bachelor's degree in Engineering with 7+ years of related experience, or Master's degree in Engineering with 5+ years of related experience Medical device industry experience Experience leading Corrective and Preventive Action investigations Experience assessing complex product, process, and quality issues Experience developing and documenting CAPA records Experience reviewing test data, quality data, and performance data Experience conducting root cause analysis and corrective action planning Experience applying statistical techniques to quality monitoring data Experience supporting audits or formal quality review meetings Knowledge of CAPA requirements within a regulated manufacturing environment Preferred Skills Experience supporting CAPA remediation or quality system recovery efforts Experience with PRIDE problem solving or similar structured root cause analysis methods Experience leading CAPA Review Board discussions Experience supporting medical device audits Experience analyzing nonconformance trends and quality system data Experience managing CAPA timelines, deliverables, and effectiveness checks Job Responsibilities Lead product and process CAPA investigations from issue identification through closure Assess issue descriptions, investigation scope, supporting data, and documented evidence Review test results, performance data, quality records, and other CAPA data sources Lead root cause analysis for complex quality, product, and process issues Develop corrective and preventive action plans based on investigation findings Complete CAPA records, documentation, and required quality system deliverables Manage CAPA schedules, milestones, meetings, and project deliverables Coordinate CAPA activities with engineering, quality, manufacturing, and other functional groups Represent CAPA records during audits and CAPA Review Board meetings Analyze quality monitoring data to identify existing or potential causes of nonconformances Apply statistical analysis to support investigation conclusions and corrective action decisions Track implementation of corrective actions through effectiveness monitoring Support CAPA program improvement efforts and quality system remediation activities Ensure CAPA action plans include defined resources, implementation steps, and measurable outcomes