CAPA Engineer (Remote - US) at Jobgether

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CAPA Engineer (Remote - US) at Jobgether. This position is posted by Jobgether on behalf of a partner company. We are currently looking for a . CAPA Engineer. in the . United States. .. This role is ideal for a detail-oriented quality professional who thrives in a regulatory and process-driven environment. You will lead and execute Corrective and Preventive Action (CAPA) investigations as well as Non-Conformance (NC) activities, ensuring compliance, consistency, and high-quality outcomes. The position requires collaboration with cross-functional teams to drive continuous improvement in root cause analysis and CAPA execution, while providing guidance, training, and mentorship to other team members. You will be instrumental in implementing process enhancements, monitoring KPIs, and supporting audits and inspections. The environment emphasizes both independent problem-solving and effective team collaboration, with a focus on maintaining regulatory compliance and operational excellence.. . Accountabilities. Lead CAPA and NC investigations, ensuring thorough root cause analysis and compliance with regulatory requirements.. Monitor and drive timely execution of CAPA/NC deliverables, reporting status to management and review boards.. Provide guidance, coaching, and mentoring to CAPA teams and junior staff.. Develop and deliver process training to maintain high levels of process knowledge.. Implement process improvements and support audits/inspections by providing documentation and responses.. Analyze CAPA/NC data to identify trends and recommend proactive solutions.. Build productive relationships across teams and departments to ensure process effectiveness.. . Bachelor’s degree required; advanced degree or equivalent work experience considered.. 2–5 years of related experience in CAPA, NC, or quality system management.. Knowledge of ISO 13485 and 21 CFR Part 820.100.. Strong analytical, problem-solving, and project management skills.. Detail-oriented, self-motivated, resourceful, and confident.. Excellent verbal and written communication skills.. Demonstrated ability to apply continuous improvement practices and drive quality results.. Familiarity navigating CAPAs through a formal Quality System.. . Company Location: United States.