CAPA Quality Engineer

Job Title: CAPA Quality Engineer

Location: Murrysville, Pennsylvania (Hybrid)

Job Summary: We are seeking a skilled professional to facilitate product and process Corrective and Preventive Action (CAPA) investigations, driving solutions from identification to implementation. Our team values strong project management skills, analytical expertise, and an ability to collaborate across functions to restore and maintain a robust CAPA program.

• Facilitate CAPA investigations, overseeing activities from issue identification through to effectiveness monitoring.
• Project manage all aspects of CAPA activity, including resource commitment, meeting scheduling, and deliverable tracking per project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings; mentor cross-functional teams on root cause analysis techniques.
• Analyze quality monitoring data and apply statistical techniques to identify existing and potential causes of non-conformances.

• Bachelor’s engineering degree with more than 5 years of related experience, or a Master’s degree with more than 3 years of related experience.
• Demonstrated knowledge of root cause analysis tools and techniques, and strong experience leading investigations and corrective actions.
• Strong understanding of global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
• Excellent written and verbal communication skills, with proven ability to partner with all levels of management and influence cross-functional teams.