Senior Quality Engineer — CAPA & Process Excellence

Johnson & Johnson Co.; Irving (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Johnson & Johnson is recruiting a Staff Quality Engineer to be located in Irving, TX. The role serves as a senior technical leader within Quality Operations, driving systemic process improvements and ensuring regulatory compliance across Quality Systems, CAPA, and Risk Management.

You will mentor quality professionals and influence cross-functional stakeholders in Operations, Engineering, Supply Chain, Manufacturing, and Regulatory groups.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 6+ years related manufacturing experience is desired.
• ASQ CQE/CQA/CQM or Process Excellence certification preferred.
• Statistical methods, Lean and Six Sigma familiarity required.
• Hands-on troubleshooting and problem-solving abilities required.

Responsibilities

• Provide technical leadership for complex product, process, supplier, and manufacturing nonconformance investigations.
• Identify recurring trends and systemic quality issues for preventive action.
• Lead site-level CAPA initiatives and risk-based quality improvements.
• Provide leadership for process validations, revalidations, and equipment qualifications.
• Review validation strategies, reports, and risk assessments.
• Lead strategic process improvements using Lean, Six Sigma, and statistical analysis.

Skills

Project management

Quality engineering

Statistics & DOE

Lean Six Sigma

GMP/ISO knowledge

Education

Bachelor's degree in engineering or related field

Job description

Johnson & Johnson is recruiting a Staff Quality Engineer to be located in Irving, TX. The role serves as a senior technical leader within Quality Operations, driving systemic process improvements and ensuring regulatory compliance across Quality Systems, CAPA, and Risk Management.

You will mentor quality professionals and influence cross-functional stakeholders in Operations, Engineering, Supply Chain, Manufacturing, and Regulatory groups.