Staff Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson is currently recruiting for a Staff Quality Engineer. This position will be located in Irving, TX.

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.

• →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

·         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.
• An ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
• 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
• This position will involve periodic entry into Controlled Manufacturing Environment production environment which requires certain preparation and gowning practices.