Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations, ensuring supplier compliance to applicable requirements and driving robust supplier qualification, development, and performance management processes.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical field
• 3–5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
• Strong knowledge of ISO 13485 and medical device regulatory requirements
• Experience with supplier audits, qualification, and risk-based supplier management
• Experience supporting NPI or design transfer activities strongly preferred
• Strong understanding of manufacturing processes, validation, and quality systems
• Experience with contract manufacturing and global supply chains
• Ability interpret mechanical drawings (CAD files)
• Familiarity with statistical tools, risk analysis (FMEA), and CAPA systems
• Experience in lean manufacturing or continuous improvement environments
• Strong technical judgment and problem-solving skills
• Ability to lead supplier interactions and drive accountability
• Excellent communication and cross-functional collaboration skills
• Strong root cause analysis and data-driven decision-making capability
• Ability to manage multiple priorities in a fast-paced NPI and production environment
• High attention to detail and regulatory compliance mindset
• Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel