Senior Supplier Quality Engineer (FDA/ISO)

Soho Square Solutions; El Paso (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Soho Square Solutions in El Paso, TX is seeking an experienced Supplier Quality Engineer (SQE) to ensure suppliers meet quality and regulatory standards. You will collaborate with Procurement, Operations, Manufacturing Engineering, R&D and Quality to drive supplier performance and risk management.

The role leads supplier quality initiatives, audits, CAPAs/SCARs, and change management while supporting supplier qualification, NPI, and process improvements.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years Supplier Quality and/or Supplier Development experience.
• Understanding of FDA 21 CFR 820, ISO 13485, ISO 14971 requirements.
• Experience in GMP-regulated manufacturing environments.

Responsibilities

• Collaborate with suppliers and internal partners to ensure robust materials, products, processes, and quality systems.
• Manage supplier quality performance through data analysis, trend monitoring, and risk assessment.
• Lead supplier quality initiatives, supplier qualification activities, investigations, CAPA/SCAR, audits and risk management.
• Plan, execute, document, and follow up on supplier quality system audits.
• Support FDA inspections and regulatory audits.

Skills

Bilingual English/Spanish

Analytical thinking

Project management

Quality systems

GMP auditing

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Quality Management Systems

Job description

Soho Square Solutions in El Paso, TX is seeking an experienced Supplier Quality Engineer (SQE) to ensure suppliers meet quality and regulatory standards. You will collaborate with Procurement, Operations, Manufacturing Engineering, R&D and Quality to drive supplier performance and risk management.

The role leads supplier quality initiatives, audits, CAPAs/SCARs, and change management while supporting supplier qualification, NPI, and process improvements.