Supplier Quality Engineer

Soho Square Solutions; El Paso (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Soho Square Solutions in El Paso, TX, seeks a Supplier Quality Engineer (SQE) to manage supplier quality performance and ensure regulatory compliance in a regulated manufacturing environment.

You will drive CAPA, SCAR, and investigations, oversee supplier qualification and validation, and partner with cross-functional teams to resolve quality issues and reduce risk.

Qualifications

• Bachelor's Degree in Engineering or 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.

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.

Skills

Analytical skills

Problem solving

Project management

Lean Six Sigma

Education

Bachelor's Degree in Engineering or related technical discipline

Tools

CAPA

SCAR

Audits

Job description

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