Supplier Quality Engineer (SQE)

Location: El Paso, TX

Job Type: Contract-to-Hire

Job Summary

We are seeking a Supplier Quality Engineer (SQE) to manage supplier quality performance, ensure regulatory compliance, and drive continuous improvement initiatives within a regulated manufacturing environment. The ideal candidate will work closely with suppliers and cross-functional teams to resolve quality issues, reduce risk, support audits, and improve supplier processes and product quality.

Key Responsibilities

• Manage supplier quality performance through audits, metrics, risk assessments, and supplier development activities.
• Lead supplier audits and ensure compliance with FDA, ISO 13485, ISO 14971, GMP, and quality system requirements.
• Drive supplier investigations, CAPA, SCAR, root cause analysis, and corrective action effectiveness.
• Support supplier qualification, validation, and change management activities.
• Partner with Procurement, Manufacturing, Operations, Engineering, Quality, and R&D teams to resolve supplier-related issues.
• Lead continuous improvement projects using Lean Six Sigma tools such as DMAIC, FMEA, SPC, MSA, DOE, and Kaizen.
• Support regulatory inspections, supplier compliance reviews, and risk management initiatives.

Required Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• 5+ years of Supplier Quality, Quality Engineering, or Supplier Development experience.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP-regulated environments.
• Experience conducting supplier audits and managing supplier quality systems.
• Hands-on experience with CAPA, SCAR, investigations, non-conformance management, and validation activities.
• Strong analytical, problem-solving, and project management skills.

Preferred Qualifications

• Medical Device, Pharmaceutical, Biotechnology, or other highly regulated manufacturing experience.
• Lean Six Sigma Green Belt/Black Belt or CQE certification.
• Bilingual English/Spanish communication skills preferred