Principal Supplier Quality Engineer

Job Summary

To provide quality oversight for Contract Manufacturing Organizations (CMOs) producing finished medical devices, the full-time Principal Supplier Quality Engineer will manage supplier performance, address quality issues, and develop strategic quality roadmaps while working remotely within the United States.

Key responsibilities

• Provide end-to-end quality oversight for assigned CMOs, ensuring compliance and performance standards are met
• Monitor supplier performance through quality metrics and drive corrective actions for continuous improvement
• Lead supplier quality activities including CAPAs, SCARs, and complaint investigations to ensure accountability and effectiveness

Required qualifications

• Bachelor's degree in engineering or scientific field with at least 6 years of related experience, or a Master's degree with at least 5 years of experience in Supplier Quality Engineering
• Experience in a highly regulated industry
• Proven expertise in managing suppliers or CMOs, including audits and quality monitoring
• Knowledge of manufacturing process controls and quality engineering tools
• In-depth knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, ISO/EN standards)