Supplier Quality Engineer

Soho Square Solutions; El Paso (TX); On-site; USD 75,000 - 110,000; Full time

Job summary

Soho Square Solutions in El Paso, TX seeks an experienced Supplier Quality Engineer (SQE) to lead supplier and manufacturing quality initiatives in a regulated production environment. You will manage supplier quality, audits, SCARs, nonconformances, CAPA, and continuous improvement to meet regulatory and customer quality requirements.

You will collaborate across Manufacturing, Engineering, Supply Chain, Operations and Quality to improve supplier performance, investigate issues, and ensure robust

Qualifications

• Bachelor's Degree in Engineering, Quality, Manufacturing, Life Sciences, or related field.
• Experience in Supplier Quality Engineering or related quality function.
• Proficient with SCAR, CAPA, and nonconformance investigations.
• Experience with FDA, GMP, ISO quality standards and change control.
• Familiar with quality tools such as FMEA and risk management.

Responsibilities

• Lead supplier quality activities including qualification, monitoring, and development.
• Drive SCARs and ensure timely closure through root-cause analysis.
• Conduct supplier audits and assessments for compliance with quality system requirements.
• Investigate supplier nonconformances, deviations, complaints, and quality issues.
• Utilize root cause analysis tools such as 5 Whys, Fishbone Diagrams, and FMEA to resolve quality challenges.
• Support CAPA activities and verify implementation effectiveness.
• Collaborate with suppliers to improve manufacturing processes, quality systems, and product performance.
• Analyze supplier performance metrics, defect trends, and quality data to identify improvement opportunities.
• Participate in change control activities and evaluate quality impacts of material, process, or supplier changes.
• Support validation, inspection, and testing activities as required.
• Review and maintain quality documentation, procedures, audit reports, risk assessments, and investigation records.
• Ensure compliance with FDA, GMP, ISO and company quality system requirements.
• Support internal audits, supplier audits, customer audits, and regulatory inspections.
• Partner with cross-functional teams to resolve quality issues and drive continuous improvement initiatives.
• Provide technical guidance and quality training related to supplier quality requirements and best practices.

Skills

SCAR Management

CAPA

Nonconformance Investigations

Supplier Quality Systems

FDA Regulations

GMP Requirements

ISO Quality Standards

Change Control

Quality Management Systems

Quality Audits

Education

Bachelor's Degree in Engineering/Quality/Manufacturing or related field

Tools

FMEA

Statistical Analysis

Process Capability Studies

Risk Management

Job description

We are seeking an experienced Supplier Quality Engineer (SQE) to support supplier quality and manufacturing quality initiatives in a regulated production environment. The successful candidate will be responsible for supplier quality management, supplier audits, SCAR administration, nonconformance investigations, CAPA activities, and continuous improvement programs to ensure compliance with regulatory, customer, and company quality requirements.

This role will work cross-functionally with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams to drive supplier performance, reduce quality issues, and maintain high standards of product quality and compliance.

Key Responsibilities

• Lead supplier quality activities, including supplier qualification, performance monitoring, and supplier development initiatives.
• Drive Supplier Corrective Action Requests (SCARs) and ensure timely closure through effective root cause analysis and corrective actions.
• Conduct supplier audits and assessments to verify compliance with quality system requirements and industry standards.
• Investigate supplier-related nonconformances, deviations, complaints, and quality issues.
• Utilize root cause analysis tools such as 5 Whys, Fishbone Diagrams, and FMEA to resolve quality challenges.
• Support CAPA activities and verify implementation effectiveness.
• Collaborate with suppliers to improve manufacturing processes, quality systems, and product performance.
• Analyze supplier performance metrics, defect trends, and quality data to identify improvement opportunities.
• Participate in change control activities and evaluate quality impacts of material, process, or supplier changes.
• Support validation, inspection, and testing activities as required.
• Review and maintain quality documentation, procedures, audit reports, risk assessments, and investigation records.
• Ensure compliance with FDA, GMP, ISO, and company quality system requirements.
• Support internal audits, supplier audits, customer audits, and regulatory inspections.
• Partner with cross-functional teams to resolve quality issues and drive continuous improvement initiatives.
• Provide technical guidance and quality training related to supplier quality requirements and best practices.

Required Qualifications

• Bachelor's Degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical field.
• Experience in Supplier Quality Engineering, Quality Engineering, Manufacturing Quality, or a related quality function.
• Strong experience with:
• SCAR Management
• CAPA
• Nonconformance Investigations
• Supplier Quality Systems
• Working knowledge of:
• FDA Regulations
• GMP Requirements
• ISO Quality Standards
• Change Control Processes
• Quality Management Systems
• Experience using quality tools such as FMEA, Statistical Analysis, Process Capability Studies, and Risk Management methodologies.
• Excellent problem-solving, communication, and stakeholder management skills.

Preferred Qualifications

• Auditor Certification (ASQ CQA, ISO Lead Auditor, or equivalent) is highly preferred.
• Experience supporting medical device, pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience with supplier development programs and supplier performance improvement initiatives.
• Knowledge of validation and quality system processes.