Supplier Quality Engineer

Supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. Ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.

Responsibilities

• Support supplier qualification activities for New Product Introduction (NPI) projects
• Conduct supplier assessments in accordance with established risk-based procedures
• Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
• Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
• Review supplier documentation including certifications, quality records, and validation evidence
• Support supplier readiness activities for production launch, including process and quality system evaluations
• Participate in design transfer and process validation activities involving suppliers
• Support supplier quality oversight for assigned NPI projects and production suppliers
• Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
• Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment, root cause analysis, and resolution of supplier-related quality issues
• Perform risk-based supplier re-evaluations and periodic assessments
• Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
• Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
• Support external and internal audits involving supplier quality systems

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree
• 1-3 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
• Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)