Quality Engineer: Drive Compliance & Continuous Improvement

bdx; El Paso (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

BD in the United States (TX, El Paso) is seeking a Quality Engineer to provide quality engineering support for manufacturing, drive CAPA investigations, and ensure compliance with FDA/ISO/GMP. You will develop validation plans, participate in change control, and lead improvements across processes with cross-functional teams.

Qualifications include a BA/BS in Engineering, 4+ years in medical devices quality engineering (or 2+ years with a MS), knowledge of 21 CFR 820 and ISO 13485, and strong

Qualifications

• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or Pharmaceutical GMP requirements (21 CFR Parts 210/211).
• Knowledge of ISO 13485 and risk management principles (ISO 14971) for medical devices.
• Root Cause Analysis, CAPA, and Investigation Management.
• Process Validation and Test Method Validation.
• Statistical Analysis and Process Capability.
• Change Control and Risk Assessment.
• Audit Readiness and Regulatory Compliance.
• Continuous Improvement and Lean Manufacturing principles.
• Strong technical writing and documentation skills.
• Cross-functional collaboration and project management.
• CQE certification or ASQ certification is a plus.
• English communication skills required; bilingual preferred.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure compliance with FDA/ISO/GMP.
• Lead investigations related to nonconformances, CAPA, and other quality events to determine root cause.
• Evaluate processes and data to identify trends and drive improvements.
• Develop, review, and approve quality documentation and validation activities.
• Support product/process validation including IQ/OQ/PQ and cleaning/software validation.
• Participate in change control and assess regulatory impact.
• Use quality tools (FMEA, SPC, RCA) and risk management techniques.
• Monitor quality metrics and recommend improvements; collaborate cross-functionally.
• Support internal and regulatory audits and implement corrective actions.
• Provide training and guidance on quality requirements to staff.
• Promote a culture of quality and compliance throughout the organization.

Skills

FDA QSR

ISO 13485

Risk management

CAPA

Process validation

IQ/OQ/PQ

Statistical analysis

Process capability

Audit readiness

Regulatory compliance

Lean manufacturing

Technical writing

Cross-functional collaboration

CQE certification

Bilingual EN/ES

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering preferred

Tools

IQ/OQ/PQ

Job description

BD in the United States (TX, El Paso) is seeking a Quality Engineer to provide quality engineering support for manufacturing, drive CAPA investigations, and ensure compliance with FDA/ISO/GMP. You will develop validation plans, participate in change control, and lead improvements across processes with cross-functional teams.

Qualifications include a BA/BS in Engineering, 4+ years in medical devices quality engineering (or 2+ years with a MS), knowledge of 21 CFR 820 and ISO 13485, and strong