Principal Quality Engineer - CAPA

Job Summary

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

Key Responsibilities

• Serve as the Global Process Owner for the CAPA subsystem, ensuring compliance and effectiveness
• Facilitate CAPA Review Boards and lead investigations, ensuring robust problem definition and effectiveness checks
• Act as the Subject Matter Expert during internal and external audits related to CAPA and Non-Conformance

Required Qualifications

• Bachelor's degree in Engineering or a related Life Science discipline
• 8+ years of Quality Engineering or QMS experience in Medical Devices with CAPA expertise
• Demonstrated experience with regulatory bodies during inspections
• Preferred: Master's degree or Advanced Certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt)
• Deep knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR