Supplier Quality Engineer 3
On-site · Morrisville, North Carolina, United States
Job Summary
Supplier Quality Engineer III (SQE III) drives supplier quality performance across commodities and critical services, leads supplier qualification and approval activities, and supports new product introductions, design transfers, and supplier changes. Responsibilities include risk assessment and compliance evaluation, overseeing supplier-related quality activities (audits, SCARs, quality planning, performance reviews), driving continuous improvement from supplier performance data, and mentoring junior team members. The role requires collaboration with cross-functional teams to manage supplier risk and ensure regulatory compliance (21 CFR 820, ISO 13485, ISO 9001) and quality objectives; preferred Bachelor’s degree and 5–10 years in a regulated environment with relevant certifications (ASQ CQE) or equivalent qualifications.
Required Qualifications
- Bachelor’s degree in engineering, science, or related technical discipline
- 5–10 years of experience in a regulated industry, preferably medical devices
- Strong knowledge of applicable regulations and standards (e.g., 21 CFR 820, ISO 13485, ISO 9001)
- Experience applying statistical techniques to support quality and process improvement
- Experience in supplier quality auditing (third-party certification preferred)
- Professional certification (e.g., ASQ CQE) or equivalent technical qualification preferred
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