CAPA Quality Engineer

JOB DESCRIPTION:

Seeking a Quality Engineer with 3 5+ years of experience in Quality Systems and CAPA management within a regulated industry, preferably Medical Devices. The candidate will be responsible for reviewing, remediating, and migrating legacy CAPA records into EtQ, ensuring compliance with FDA and ISO quality standards. This role partners with Quality, Regulatory, Operations, and Engineering teams to drive CAPA investigations, root cause analysis, corrective actions, and quality system improvements.

Key Responsibilities

• Review, remediate, and migrate CAPA records into EtQ.
• Manage CAPAs from initiation through closure.
• Conduct gap assessments and documentation remediation.
• Support root cause investigations and corrective/preventive actions.
• Verify effectiveness of implemented actions.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and internal procedures.
• Collaborate with cross-functional teams on quality initiatives.
• Support CAPA training, documentation, and process improvements.
• Maintain accurate quality records and documentation.

Required Qualifications

• Bachelor's degree in Engineering or related technical field.
• 3 5+ years of Quality Engineering experience.
• Hands-on experience with CAPA processes and Quality Management Systems.
• Experience with EtQ or other electronic QMS platforms.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and quality system regulations.
• Experience with Root Cause Analysis, FMEA, Risk Management, and Quality Investigations.
• Strong technical writing, documentation review, and analytical skills.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Medical Device industry experience.
• Orthopedic device manufacturing experience.
• Knowledge of ISO 14971 Risk Management.
• Certified Quality Engineer (CQE).
• Experience with Design Controls, Statistical Analysis, Nonconformance Management, and Regulatory Audits.