Lead Supplier Quality Engineer: Drive Global Quality

Regulatory Jobs; El Paso (TX); On-site; USD 90,000 - 125,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Supplier Quality professional at our USA TX site to drive supplier quality programs and audits. You will work with procurement, R&D, engineering, and operations to resolve supplier-related issues and implement effective CAPA actions.

The role requires deep knowledge of GMP, ISO 13485, ISO 14971, and strong documentation skills. Fluency in Spanish and English is preferred for global supplier interactions.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5 years Supplier Quality/Development experience.
• Understanding of 21 CFR 820, ISO 13485, ISO 14971.
• Experience in a GMP-regulated environment (medical device/pharma).
• Experience with plant/supplier audits (GMP).
• Documentation and technical writing in regulated environments.
• Bilingual Spanish/English.
• FDA inspection experience.

Responsibilities

• Collaborate with suppliers and partners to ensure robust materials, products, processes, and systems.
• Lead root cause investigations and CAPA, driving corrective actions with suppliers.
• Manage supplier issues; plan, execute, and report supplier quality system audits.
• Partner across Procurement, R&D, Engineering, Quality, Operations to resolve supplier-related issues.
• Monitor supplier performance metrics and drive risk mitigation and issue resolution.
• Implement supplier change management including notifications and impact assessments.
• Own supplier quality projects with limited supervision and leadership.
• Apply PM/QA methodologies to SQM projects and continuous improvement initiatives.
• Analyze quality data to identify trends and drive resolution with global teams.
• Collaborate on process/product improvement with operations and franchise teams.
• Prepare Supplier Quality Agreements and engage with supplier quality managers.
• Develop/execute Quality Risk Management for supplier-related matters.

Skills

Supplier Quality

Root Cause Analysis

GMP Awareness

Bilingual Spanish/English

Education

Bachelor's degree in Engineering or related field

Job description

BD, a leading global medical technology company, seeks a Supplier Quality professional at our USA TX site to drive supplier quality programs and audits. You will work with procurement, R&D, engineering, and operations to resolve supplier-related issues and implement effective CAPA actions.

The role requires deep knowledge of GMP, ISO 13485, ISO 14971, and strong documentation skills. Fluency in Spanish and English is preferred for global supplier interactions.