Senior Quality Engineer - CAPA & Process Excellence

Brighter Signals; Irving (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Quality Engineer in Irving, TX to provide senior technical leadership in Quality Operations. The role focuses on quality systems, CAPA, process validation, risk management, and continuous improvement, mentoring professionals while influencing stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory functions.

The position requires ISO13485/cGMP knowledge, Six Sigma/Lean expertise, and hands-on problem solving to drive

Qualifications

• Knowledge of ISO13485 and/or cGMP regulations.
• Demonstrated project management and project leadership skills, including managing deliverables.
• ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.

Responsibilities

• Provide technical leadership for complex product, process, supplier, and manufacturing nonconformance investigations.
• Identify recurring trends, systemic quality issues, and opportunities for preventive action across manufacturing operations.
• Act as escalation lead for critical quality events and high-risk compliance issues.
• Lead site-level CAPA initiatives focused on systemic quality, compliance, and operational performance improvements.
• Provide Quality leadership for process validations, revalidations, equipment qualifications, and process changes.
• Review and approve validation strategies, protocols, reports, and associated risk assessments.
• Lead strategic process improvement initiatives utilizing Lean, Six Sigma, statistical analysis, and risk-based methodologies.
• Analyze quality data, nonconformance trends, complaint data, audit findings, and process metrics to identify improvement opportunities.
• Drive defect reduction, waste elimination, process capability improvement, and quality system effectiveness initiatives.
• Lead and facilitate risk assessments associated with manufacturing processes, process changes, investigations, and quality system improvements.

Skills

ISO13485 / cGMP

Project management

Six Sigma / Lean

Statistics

Troubleshooting

Education

Bachelor's degree in engineering or related technical field

Job description

Johnson & Johnson is seeking a Staff Quality Engineer in Irving, TX to provide senior technical leadership in Quality Operations. The role focuses on quality systems, CAPA, process validation, risk management, and continuous improvement, mentoring professionals while influencing stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory functions.

The position requires ISO13485/cGMP knowledge, Six Sigma/Lean expertise, and hands-on problem solving to drive