Supplier Quality Engineer

This in-person Full Time role is responsible for leading supplier quality issue resolution and driving continuous improvement to ensure consistent component and material performance for medical devices. The Supplier Quality Engineer II partners closely with suppliers and cross-functional teams to investigate nonconformances, implement corrective actions, and ensure compliance with FDA and ISO requirements.

• Lead investigation and resolution of supplier-related quality issues impacting product and manufacturing performance
• Drive supplier corrective actions using risk-based and data-driven quality tools
• Conduct supplier assessments, audits, and reviews to evaluate capability and compliance
• Evaluate supplier changes for impact to design, quality, and regulatory requirements
• Develop and maintain receiving inspection criteria and supplier quality documentation
• Support internal and external audits and regulatory inspections
• Collaborate cross-functionally with Manufacturing, R&D, and Supply Chain teams

• Bachelor’s degree in Engineering, Life Sciences, or related technical field
• 4+ years of supplier quality experience in the medical device industry
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 (AS9100 acceptable)
• Experience resolving supplier nonconformances and leading corrective actions
• Hands-on experience with electromechanical components or systems
• Strong organizational, analytical, and communication skills
• Comfortable working directly with suppliers in a hands-on quality role

• $90-110k with some wiggle room if needed based on experience