Quality Engineer, Medical Devices — CAPA & Compliance

Regulatory Jobs; El Paso (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health. The Quality Engineer will support manufacturing processes to ensure FDA/ISO/GMP compliance and lead CAPA investigations, data-driven improvements, and documentation across QA, regulatory, and operations teams.

Responsibilities include validation activities (IQ/OQ/PQ), change control, risk assessment, and collaboration with cross‑functional groups.

Qualifications

• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or Pharmaceutical GMP (21 CFR Parts 210/211).
• Knowledge of ISO 13485 and risk management (ISO 14971) for medical devices.
• Experience with CAPA, investigations, and root cause analysis.
• Experience with process validation and test method validation.
• Ability to perform statistical analysis and assess process capability.
• Familiarity with change control and risk assessment processes.
• Audit readiness and regulatory compliance experience.
• Continuous improvement and Lean manufacturing background.
• Strong technical writing and documentation skills.
• Ability to collaborate cross‑functionally and manage projects.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO/GMP compliance.
• Lead investigations related to nonconformances, deviations, complaints, OOS results, audits, and CAPA implementations.
• Analyze quality metrics to identify trends and drive continuous improvement.
• Develop, review, and approve quality docs, including procedures, specs, reports and risk assessments.
• Support IQ/OQ/PQ, cleaning, software, and test method validations.
• Participate in change control and assess regulatory impact of changes.
• Utilize quality tools (FMEA, SPC, RCCA) for risk and performance analysis.
• Collaborate with Manufacturing, Engineering, Regulatory, Quality, Supply Chain, R&D, Validation.
• Support internal, supplier, customer audits and regulatory inspections with CAPAs.
• Develop and validate inspection/test methods for reliable quality evaluation.
• Incorporate risk management throughout product lifecycle and post-market data review.
• Provide training on quality requirements and best practices to staff.
• Support regulatory submissions and FDA inspections as required.
• Promote a culture of quality, compliance, and patient focus.
• Ensure safety and company policy compliance.
• Perform other duties as assigned.

Skills

FDA QSR 820

ISO 13485

Risk management

CAPA

Process validation

Statistical analysis

Change control

Root cause analysis

Lean manufacturing

Technical writing

Cross‑functional collaboration

CQE certification

English communication

Spanish bilingual (preferred)

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Job description

BD is a leading global medical technology company focused on advancing health. The Quality Engineer will support manufacturing processes to ensure FDA/ISO/GMP compliance and lead CAPA investigations, data-driven improvements, and documentation across QA, regulatory, and operations teams.

Responsibilities include validation activities (IQ/OQ/PQ), change control, risk assessment, and collaboration with cross‑functional groups.