Senior CAPA Specialist

Senior CAPA Specialist position within the Joint Replacement division's quality management system. The role focuses on managing nonconformance and corrective/preventive action processes, applying problem-solving methodologies, and ensuring compliance with regulated industry standards.

Responsibilities

• Review and approve nonconformance and CAPA documentation for completeness and accuracy
• Facilitate and coach cross-functional teams in problem-solving techniques and methodologies
• Conduct root cause analysis and drive timely resolution of quality issues
• Maintain accurate CAPA documentation in electronic quality management systems
• Monitor CAPA metrics, prepare reports, and support quality business reviews

Requirements

• Bachelor's degree in science, engineering, or related technical field
• 2+ years experience in medical device or pharmaceutical regulated environments
• Demonstrated experience managing NC and CAPA processes including root cause analysis
• Knowledge of problem-solving methodologies and continuous quality improvement
• Experience with regulatory agencies (FDA, MoH, TUV) preferred
• Familiarity with FDA and international medical device quality system standards preferred

Compensation: $87,000 - $145,100 USD annual