Supplier Quality Engineer

About the role

The Supplier Quality Engineer will own the overall quality performance of assigned suppliers, ensuring they meet Medline’s quality standards and regulatory requirements. This role works closely with internal teams and external suppliers to drive continuous improvement across the supply chain.

Key responsibilities

• Manage a portfolio of suppliers as the primary liaison between suppliers, Corporate QA, and the Shanghai Office QA.
• Monitor supplier QMS compliance through vigilance audits, focusing on P&PC and quality control.
• Support suppliers in developing and executing master process validation plans.
• Coordinate non‑conformities, drive corrective actions (CAPA, SCAR), and follow up on audit findings.
• Track supplier capacity and purchase volumes, maintain supplier ratings, and lead improvement programs.
• Oversee supplier change requests from initiation to implementation, ensuring impact assessments and documentation transfer.
• Facilitate knowledge transfer for mass‑production approval, including pre‑production meetings and training of QC personnel.
• Identify and implement efficiency improvements in supplier quality engineering processes.

Required profile

• Bachelor’s degree in an engineering discipline.
• Minimum 3 years of experience in supplier quality management.
• Familiarity with ISO 9001 and knowledge of ISO 13485/QSR 820 is a plus.

Required skills

• Proficiency with MS Word, Excel, and PowerPoint.
• Strong data analysis capabilities.
• Experience with quality tools such as 5WHY, Fishbone diagrams, and SOP development.
• Lean and Six Sigma methodology exposure.