Senior Quality Engineer - CAPA, Process & Risk

Brighter Signals; Fort Worth (TX); On-site; USD 90,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Quality Engineer in Irving, TX, to lead Quality Operations with strategic direction across Quality Systems, CAPA, Process Validation, Risk Management and Continuous Improvement.

You will mentor professionals, drive high-impact investigations, strengthen process capability, and collaborate with Operations, Engineering, Supply Chain and Regulatory teams to improve product quality and compliance.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• Minimum 6 years of manufacturing experience.
• ISO13485 and/or cGMP knowledge.
• ASQ CQE/CQA or Process Excellence certification preferred.
• Proficient in statistics, Lean, Six Sigma and DOE methodologies.
• Hands-on troubleshooting and understanding of manufacturing equipment.

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.
• Support DFMEA, PFMEA, hazard analysis, and risk-benefit evaluations.
• Assess business performance, analyze business processes, evaluate gaps, identify process improvements, and recommend business solutions.
• Assists with providing support and training to process owners.
• Participates in project teams as directed by management. Verifies master batch records for development and validation studies and regular production.
• Provides statistical support for sampling plan and analysis, DOEs, Paretos, ANOVA, and SPC applications.
• Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
• Investigation of nonconforming material and assist with the determination of root cause, corrective action and recommendation of disposition for the Data Review Board (DRB).
• Performs other duties assigned as needed

Skills

ISO13485 / cGMP knowledge

Project management

ASQ certification / Process Excellence

Statistics & Lean & Six Sigma

Troubleshooting

Manufacturing equipment knowledge

Education

Bachelor's degree in engineering

Job description

Johnson & Johnson is seeking a Staff Quality Engineer in Irving, TX, to lead Quality Operations with strategic direction across Quality Systems, CAPA, Process Validation, Risk Management and Continuous Improvement.

You will mentor professionals, drive high-impact investigations, strengthen process capability, and collaborate with Operations, Engineering, Supply Chain and Regulatory teams to improve product quality and compliance.