Supplier Quality Engineer

About the role

The Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role 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
• Serve as a key interface between Engineering, Procurement, Quality, and the supplier base
• 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
• Sustain supplier quality activities for production materials and services, including monitoring supplier performance and supporting resolution of supplier-related quality issues
• 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

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)
• Exposure to supplier quality, manufacturing, or inspection processes preferred
• Experience supporting NPI, manufacturing, or engineering projects a plus

Skills & Competencies

• Good analytical and problem-solving skills
• Ability to work effectively in cross-functional teams
• Strong communication and documentation skills
• Ability to interpret mechanical drawings (CAD files)
• Attention to detail and commitment to quality
• Ability to manage multiple tasks in a dynamic environment
• Basic understanding of manufacturing and quality systems concepts
• Familiarity with CAPA, nonconformance, or inspection processes is a plus
• Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 10-20% travel

Preferred Certifications

• ISO 13485 Internal Auditor certification (or willingness to obtain)
• ASQ certifications (CQE, CQA, or similar) are a plus