Quality Engineer - CAPA

Job Summary

A company is looking for a Sr. Quality Engineer - CAPA.

Key Responsibilities

• Ensure compliance of the CAPA and NC system with relevant standards and regulations
• Collaborate with CAPA and NC owners to assess issues and ensure effective corrective actions
• Train and mentor CAPA and NC owners on best practices and maintain audit readiness

Required Qualifications

• Bachelor's Degree or equivalent quality/regulatory experience
• Minimum of 5 years in a Quality or Regulatory role
• At least 3 years of experience with CAPA and Nonconformance in a medical device or healthcare setting
• Deep understanding of CAPA and NC systems and regulatory requirements
• Experience with ISO 13485, FDA 21 CFR 820, and EU MDD/MDR