Staff Quality Engineer: Process Excellence & CAPA Leader

Johnson & Johnson MedTech; Irving (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is recruiting a Staff Quality Engineer for Irving, TX. This senior role provides strategic direction across Quality Systems, CAPA, validation, risk management, and continuous improvement within Quality Operations.

You will mentor professionals and influence stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory. The position leads high-impact quality investigations, strengthens process capability, and drives systemic improvements to enhance

Qualifications

• Bachelor’s degree in engineering or related technical field is required.
• Minimum 6 years manufacturing experience preferred.
• ASQ certification (CQE, CQA, CRE or CQM) or Process Excellence certification preferred.
• Knowledge of ISO13485 and/or cGMP regulations.
• Strong project management and leadership skills.

Responsibilities

• Provide technical leadership for nonconformance investigations across product, process, supplier, and manufacturing.
• Identify recurring systemic quality issues and preventive action opportunities.
• Act as escalation lead for critical quality events and high-risk compliance issues.
• Lead site-level CAPA initiatives focused on quality, compliance and performance improvements.
• Provide quality leadership for process validations, revalidations, and equipment qualifications.

Skills

Quality Engineering

Project management

Six Sigma

ISO13485 / cGMP

CQE / CQA / CQM / CRE

Statistical methods (SPC, DOEs)

Troubleshooting

Cross-functional leadership

Education

Bachelor’s degree in engineering or related technical field

Job description

Johnson & Johnson is recruiting a Staff Quality Engineer for Irving, TX. This senior role provides strategic direction across Quality Systems, CAPA, validation, risk management, and continuous improvement within Quality Operations.

You will mentor professionals and influence stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory. The position leads high-impact quality investigations, strengthens process capability, and drives systemic improvements to enhance