Quality Engineer — Medical Devices, CAPA & Compliance

Regulatory Jobs; El Paso (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Becton, Dickinson, and Company (BD) in El Paso, TX is seeking a Quality Engineer to provide manufacturing quality support and lead CAPA investigations. You will participate in validation activities, change controls, and cross-functional collaboration to ensure FDA/ISO compliance.

The role requires a bachelor’s degree in engineering and 4+ years in quality/engineering within medical devices; a master’s degree is preferred. Bilingual English/Spanish is a plus.

Qualifications

• Minimum four years of engineering or quality engineering experience in medical devices or regulated industry with a Bachelor’s degree.
• Minimum two years of experience if holding a Master’s degree.
• Knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; risk management (ISO 14971).
• Strong documentation and technical writing skills; English proficiency required; bilingual English/Spanish preferred.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO compliance.
• Lead investigations for nonconformances, CAPA, and audit findings; determine root cause and implement corrective actions.
• Assess processes and quality data to reduce defects and drive continuous improvement.
• Develop and approve quality documentation including procedures, specs, and validation plans.
• Support IQ/OQ/PQ, cleaning, software and test method validations as applicable.
• Participate in change controls and assess regulatory impact of proposed changes.
• Use statistical analysis, FMEA, and risk management to monitor quality performance.
• Collaborate with cross-functional teams to embed quality throughout product lifecycle.
• Support regulatory submissions, audits, and inspections; implement corrective actions as needed.

Skills

Root cause analysis

CAPA

Process validation

Statistical analysis

Lean manufacturing

Cross-functional collaboration

Project management

Technical writing

English communication

Quality system knowledge

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering (preferred)

Tools

CQE certification beneficial

Job description

Becton, Dickinson, and Company (BD) in El Paso, TX is seeking a Quality Engineer to provide manufacturing quality support and lead CAPA investigations. You will participate in validation activities, change controls, and cross-functional collaboration to ensure FDA/ISO compliance.

The role requires a bachelor’s degree in engineering and 4+ years in quality/engineering within medical devices; a master’s degree is preferred. Bilingual English/Spanish is a plus.