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Job Details

About the Role

We are looking for a Supplier Quality Engineer to ensure high‑quality components and services from our suppliers while meeting FDA, EU MDR, and internal QMS requirements. You will support supplier qualification, audits, problem solving, and cross‑functional collaboration.

What You’ll Do

• Manage supplier quality for components.

• Maintain and update the Approved Supplier List (ASL).

• Support or lead supplier selection and qualification activities.

• Apply quality engineering tools (SPC, capability studies, IQ/OQ/PQ).

• Lead 8D investigations for supplier corrective actions.

• Review nonconformities and customer complaints.

• Conduct supplier audits and drive closure of findings.

• Collaborate with Factory, Sourcing, CME, AME, and R\&D.

• Ensure timely delivery of conforming parts using AQL/incoming inspection methods.

• Support CAPA, supplier transfers, and process improvements.

What You Bring

• Bachelor’s degree in Engineering or related technical field and 2+ years of experience in Quality or Supplier Quality (required).

• Graduates with a newly obtained Master's degree will be considered.

• Conversant in plastic injection molding and assembly processes.

• Strong communication skills and English proficiency.

• Highly organized, dependable, and detail‑oriented.

• Proficiency with Microsoft Office (required).

• Six Sigma Green/Black Belt certification (preferred).

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