Senior Quality Engineer - Process Improvement CAPA Leader

Johnson & Johnson Co.; Dallas (TX); On-site; USD 100,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Quality Engineer to lead quality investigations and drive systemic improvements in the Irving, TX area. The role focuses on quality systems, CAPA, and process validation across operations, engineering, and regulatory functions.

You will mentor teams, manage cross-functional projects, and ensure regulatory compliance while advancing site quality strategies to improve product quality and operational excellence.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 6+ years related manufacturing experience preferred.
• Knowledge of ISO13485 and/or cGMP regulations.

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 root cause determination and corrective actions.

Skills

Quality Systems

CAPA

Process Validation

Risk Management

Continuous Improvement

Education

Bachelor's degree in Engineering

Tools

Statistics

SPC

DOEs

Job description

Johnson & Johnson is seeking a Staff Quality Engineer to lead quality investigations and drive systemic improvements in the Irving, TX area. The role focuses on quality systems, CAPA, and process validation across operations, engineering, and regulatory functions.

You will mentor teams, manage cross-functional projects, and ensure regulatory compliance while advancing site quality strategies to improve product quality and operational excellence.