Job Description
Supplier Quality Engineer (SQE)
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Location: El Paso, TX
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Job Type: Contract-to-Hire
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Job Summary
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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.
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Key Responsibilities
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- 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.
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Required Qualifications
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- 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.
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Preferred Qualifications
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- 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
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