CAPA Engineer - Remote

Overview

This position 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.

In Short

• 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.

Requirements

• Detail-oriented with a strong understanding of regulatory compliance.
• Experience in leading CAPA and NC investigations.
• Ability to analyze data and identify trends.
• Strong communication and mentoring skills.
• Experience in process improvement initiatives.
• Ability to work both independently and collaboratively.

Benefits

• Opportunity to work in a dynamic and supportive environment.
• Professional development and training opportunities.
• Collaboration with cross-functional teams.
• Engagement in continuous improvement processes.