Principal Supplier Quality Engineer

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)