CAPA Engineer (Remote - US)

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.

Requirements

• 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.

Benefits

• Competitive salary and benefits package.
• Professional development opportunities and process improvement initiatives.
• Collaborative and supportive team environment.
• Flexible work arrangements where possible.
• Exposure to regulatory compliance, audits, and cross-functional project experience.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!