CAPA Process Analyst

Job Summary

A company is looking for a CAPA Process Analyst II to join their Quality Systems department supporting the Research & Development division.

Key Responsibilities

• Lead investigations of nonconformances within the CAPA program to ensure compliance with regulatory standards
• Develop audit-ready CAPA records and support timely closure of investigations
• Facilitate cross-functional collaboration to determine root causes and implement corrective and preventive actions

Required Qualifications

• Bachelor's degree in engineering or a related discipline
• 4+ years of experience in CAPA, Quality Systems, or a related role within a regulated industry, preferably medical devices
• Proficiency with root cause investigation tools such as 5 Whys, Fishbone, or 6Ms
• Strong technical writing skills for developing clear, audit-ready documentation
• Excellent organizational and time management skills