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Supplier Quality Engineer

SOHO Square Solutions

Supplier Quality Engineer (SQE)Location: El Paso, TXJob Type: Contract-to-HirePlease ensure you read the below overview and requirements for this employment opportunity completely.Job SummaryWe 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 ResponsibilitiesManage 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 QualificationsBachelor'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 QualificationsMedical Device, Pharmaceutical, Biotechnology, or other highly regulated manufacturing experience. xhyhwjd Lean Six Sigma Green Belt/Black Belt or CQE certification.Bilingual English/Spanish communication skills preferred

Vacancy posted 3 days ago
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