Staff Quality Engineer

Location: Irving, TX (also posted for Dallas and Fort Worth, TX) | Job Function: Supply Chain Engineering | Sub Function: Quality Engineering | Category: Scientific/Technology

About the role

The Staff Quality Engineer serves as a senior technical leader within Quality Operations, providing strategic direction and subject matter expertise across Quality Systems, Nonconformance Management, CAPA, Process Validation, Risk Management, and Continuous Improvement. This role leads complex cross-functional quality initiatives, drives systemic process improvements, ensures regulatory compliance, and mentors quality professionals while influencing stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory functions. The Staff Quality Engineer is expected to lead high-impact quality investigations, identify and address systemic issues, strengthen process capability, and support the development and execution of site quality strategies that improve product quality, compliance, and operational excellence.

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.
• 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 the determination of root cause, corrective action and recommendation of disposition for the Data Review Board (DRB).
• Perform other duties as assigned.

Requirements

• Bachelor's degree in engineering or related technical field (required).
• Minimum of 6 years related manufacturing experience (desired).

Qualifications & Skills

• Knowledge of ISO 13485 and/or cGMP regulations.
• Demonstrated project management and project leadership skills, including managing deliverables.
• ASQ certification (CQE, CQM, CRE, or CQA), Six Sigma (Green Belt, Black Belt, etc.), or Process Excellence certification (preferred).
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies (required), including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Ability to perform "hands on" troubleshooting and problem solving (required).
• Good technical understanding of manufacturing equipment and processes (required).
• Demonstrated project management and project leadership abilities (required).
• Ability to periodically interact with associates and processes in a Controlled Manufacturing Environment, including entry into production areas requiring preparation and gowning practices.