Senior Quality Engineer - CAPA & Process Excellence

Brighter Signals; Dallas (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson is recruiting for a Staff Quality Engineer to be located in Irving, TX. You will lead complex quality investigations, drive CAPA programs, and mentor quality professionals across operations, engineering, supply chain, manufacturing and regulatory functions.

The role emphasizes strategic direction in Quality Systems, risk management, process validation, and continuous improvement, ensuring regulatory compliance and product quality.

Qualifications

• Knowledge of ISO13485 and/or cGMP regulations.
• Proven project management and leadership skills.
• ASQ CQE/CQA or Six Sigma certification preferred.
• Experience with statistics, Lean and Six Sigma methodologies.
• Hands-on troubleshooting and shop-floor problem solving.

Responsibilities

• Provide technical leadership for complex nonconformance investigations.
• Identify recurring quality issues and preventive actions.
• Act as escalation lead for critical quality events.
• Lead CAPA initiatives for systemic quality improvements.
• Provide leadership for process validations and equipment qualifications.
• Review validation strategies and risk assessments.
• Lead improvement initiatives using Lean and Six Sigma methods.
• Analyze quality data and process metrics to identify improvements.
• Drive defect reduction and waste elimination.
• Assist with training process owners.

Skills

Quality leadership

Project management

Statistics & Six Sigma

Troubleshooting

Regulatory compliance

Education

Bachelor's degree in engineering or related technical field

Job description

Johnson & Johnson is recruiting for a Staff Quality Engineer to be located in Irving, TX. You will lead complex quality investigations, drive CAPA programs, and mentor quality professionals across operations, engineering, supply chain, manufacturing and regulatory functions.

The role emphasizes strategic direction in Quality Systems, risk management, process validation, and continuous improvement, ensuring regulatory compliance and product quality.