Quality Engineer - MedTech Process & CAPA Leader

BD; El Paso (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

BD is seeking a Quality Engineer to provide engineering support for manufacturing processes, ensuring FDA/ISO compliance and driving CAPA and continuous improvement initiatives. The role requires collaboration across Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to uphold quality standards throughout the product lifecycle.

Ideal candidates will have a Bachelor’s in Engineering with 4+ years of related experience, and a preference for a Master’s degree.

Qualifications

• Bachelor’s degree in Engineering is required.
• Master’s degree in Engineering is preferred.
• CQE or ASQ certification is a plus.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO compliance.
• Lead investigations into nonconformances, deviations, customer complaints, CAPA and other quality events to determine root cause and implement corrective actions.
• Evaluate manufacturing processes and quality data to identify trends and drive continuous improvement initiatives.
• Develop, review, and approve quality documentation and validation activities as applicable.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs and other teams to integrate quality requirements into products and processes.
• Support internal and regulatory audits, supplier audits, and inspections.

Skills

Root Cause Analysis

CAPA

Process Validation

Statistical Analysis

Lean Manufacturing

Cross-functional collaboration

Project management

Technical writing

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

BD is seeking a Quality Engineer to provide engineering support for manufacturing processes, ensuring FDA/ISO compliance and driving CAPA and continuous improvement initiatives. The role requires collaboration across Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to uphold quality standards throughout the product lifecycle.

Ideal candidates will have a Bachelor’s in Engineering with 4+ years of related experience, and a preference for a Master’s degree.