Quality Engineer – MedTech: CAPA, Validation & Compliance

Becton Dickinson NA; El Paso (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Becton, Dickinson and Company (BD) is seeking a Quality Engineer to provide manufacturing quality support in El Paso, TX. The role emphasizes investigations, CAPA, process validation, and risk management within a regulated medical device environment.

The successful candidate will collaborate across Manufacturing, Engineering, Regulatory, and Quality teams to ensure compliance and drive continuous improvement in product quality and process capability.

Qualifications

• Bachelor's degree in Engineering required; Master's preferred.
• 4+ years in engineering or quality engineering in medical devices or pharmaceuticals.
• Experience with FDA quality systems, ISO 13485 and risk management preferred.

Responsibilities

• Provide quality engineering support for manufacturing to ensure FDA/ISO/GMP compliance.
• Lead investigations; determine root cause and implement CAPA.
• Evaluate processes and data to identify trends and drive continuous improvement.
• Develop and approve quality documentation and validation protocols.
• Support IQ/OQ/PQ and validation activities; participate in change control.
• Utilize statistical tools, FMEA, risk assessments, and PSC methods.
• Collaborate with multiple teams to embed quality throughout product lifecycles.
• Support audits, regulatory inspections, and corrective actions.

Skills

FDA QSR 21 CFR 820

ISO 13485

CAPA & RCA

Process Validation

Statistical Analysis

Lean Manufacturing

Change Control

Regulatory Compliance

Documentation & Writing

Cross-functional Collaboration

Education

Bachelor's degree in Engineering

Master's degree in Engineering (preferred)

Job description

Becton, Dickinson and Company (BD) is seeking a Quality Engineer to provide manufacturing quality support in El Paso, TX. The role emphasizes investigations, CAPA, process validation, and risk management within a regulated medical device environment.

The successful candidate will collaborate across Manufacturing, Engineering, Regulatory, and Quality teams to ensure compliance and drive continuous improvement in product quality and process capability.