Quality Systems Engineer - CAPA - Remote

Overview

As the Quality Systems Engineer - CAPA, you will be responsible for maintaining robust Issue Escalation processes across iRhythm, ensuring compliance with quality and regulatory standards.

In Short

• Advocate for cross-functional collaboration and compliance.
• Drive quality system CAPA and Issue Escalation performance globally.
• Provide training and guidance on CAPA and NC investigations.
• Ensure compliance with U.S. and international standards.
• Assess issue descriptions with CAPA and NC owners.
• Train and mentor CAPA and NC owners in best practices.
• Maintain audit-readiness for quality system audits.
• Engage in continuous improvement of the Issue Escalation program.

Requirements

• Bachelor’s Degree or equivalent quality/regulatory experience.
• 5 years of experience in a Quality or Regulatory role.
• 3 years of experience with CAPA and Nonconformance activities.
• Deep understanding of CAPA and NC systems.
• Experience in Issue Escalation and Field Risk Assessment.
• Knowledge of ISO 13485 and FDA regulations.
• Strong investigational and problem-solving skills.
• Demonstrated Project Management abilities.
• Excellent communication and interpersonal skills.
• Basic statistical methods including trend analysis.

Benefits

• Competitive salary range.
• Opportunity to work in a leading digital healthcare company.
• Focus on patient care and innovative solutions.
• Collaborative work environment.