Staff Quality Engineer

Johnson & Johnson Innovative Medicine•Fort Worth, TX

3d•Onsite

About The Position

Johnson & Johnson is hiring a Staff Quality Engineer in Irving, Texas. This senior technical leader within Quality Operations provides strategic direction and subject matter expertise across Quality Systems, Nonconformance Management, CAPA, Process Validation, Risk Management, and Continuous Improvement. The 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 leads high-impact quality investigations, identifies and addresses systemic issues, strengthens process capability, and supports the development and execution of site quality strategies to improve product quality, compliance, and operational excellence. The position periodically requires entry into a Controlled Manufacturing Environment, including associated preparation and gowning practices.

Requirements

Bachelor’s degree in engineering or a related technical field.
A minimum of 6 years of related manufacturing experience is desired.
Knowledge of ISO 13485 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, including Measurement System Analysis, SPC, DOEs, and Reliability.
Ability to perform hands-on troubleshooting and problem solving.
Good technical understanding of manufacturing equipment and processes.
Ability to periodically interact with associates and processes in a Controlled Manufacturing Environment.
Ability to enter a Controlled Manufacturing Environment production area, following preparation and gowning practices.

Nice To Haves

ASQ certification (CQE, CQM, CRE, or CQA).
Six Sigma certification, such as Green Belt or Black Belt.
Process Excellence certification.

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 using 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.
Support and train 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 plans 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 determining root cause, corrective action, and disposition recommendations for the Data Review Board (DRB).
Perform other duties as assigned.