Staff Quality Engineer

Johnson & Johnson

. Provide technical leadership for complex product, process, supplier, and manufacturing nonconformance investigations.

Posted 10/20/2026full-timeIrving • Texas • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality leadership, process validation, and compliance within manufacturing environments, utilizing Lean and Six Sigma methodologies to drive continuous improvement and operational excellence.

Highest-signal resume keywords

Quality LeadershipLean MethodologySix Sigma MethodologyProject ManagementISO13485 Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ValidationStatistical AnalysisRoot Cause AnalysisCAPA InitiativesRisk AssessmentMeasurement System AnalysisSPC ApplicationsDOEsParetosANOVA

Soft Skills

Problem SolvingTroubleshootingTeam CollaborationTraining and Support

Industry Keywords

CGMP RegulationsControlled Manufacturing EnvironmentNonconformance InvestigationsQuality System EffectivenessManufacturing Operations

About the role

Key responsibilities & impact

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.
Assist with providing support and training to process owners.
Participate in project teams as directed by management.
Verify master batch records for development and validation studies and regular production.
Provide 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.
Investigate nonconforming material and assist with determination of root cause, corrective action, and disposition recommendations for the Data Review Board (DRB).
Perform other duties assigned as needed.

Requirements

What you’ll need

A bachelor’s degree is required in engineering or related technical field.
A minimum of 6 years related manufacturing experience is desired.
Knowledge of ISO13485 and/or cGMP regulations.
Demonstrated project management and project leadership skills, including managing deliverables.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required, including Measurement System Analysis, SPC, DOEs, Reliability, etc.
The ability to perform "hands on" troubleshooting and problem solving is required.
Good technical understanding of manufacturing equipment and processes is required.
Demonstrated project management and project leadership abilities are required.
Ability to periodically interact with associates and processes in a special environment such as a Controlled Manufacturing Environment.
Periodic entry into a Controlled Manufacturing Environment production environment, requiring preparation and gowning practices.

Benefits

Comp & perks

Inclusive work environment
Equal opportunity employment
Interview process accommodations for applicants with disabilities