Johnson & Johnson MedTech
Quality Engineer II – Johnson & Johnson MedTech – Irvine, CA
Job Summary
The Quality Engineer II will supervise, execute, and coordinate quality assurance activities to ensure effective product quality processes throughout the lifecycle of products. The role is pivotal in New Product Development (NPD) teams, supporting design verification, process validation, and qualification activities in compliance with company Quality System policies and applicable regulatory standards. Responsibilities
Work with R&D, Operations, and other functional groups to support new product development, engineering projects, and quality assurance activities. Apply Quality Engineering tools and processes to develop and implement practices that facilitate efficient product and process development and transfer. Lead continuous improvement initiatives for quality and customer satisfaction. Support the Non‑Conformance Report (NCR) process and develop associated risk‑management plans (AFMEA, DFMEA, PFMEA). Write, review, and approve process and product validation protocols, equipment qualifications, and engineering change orders. Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, and improve process capability. Support sterility, biocompatibility, and packaging test requirements per standard operating procedures. Ensure design control requirements are met, including Design Traceability, GSPR compliance, and proper transfer to manufacturing. Conduct technical problem solving, failure analysis, and root‑cause determination. Make independent engineering decisions and represent the organization in technical conferences. Present business‑related issues or opportunities to management. Maintain compliance with all regulatory, company, and ethical policies. Qualifications
Bachelor’s degree in engineering or a scientific field (preferred). Minimum 2 years of quality, manufacturing, or R&D experience in a medical device or regulated industry. Strong analytical skills with ability to define problems, collect data, establish facts, and provide recommendations. Knowledge of regulatory, technical, and business requirements for due diligence assessments. Experience with quality standards implementation and auditing. Proficiency in Design for Six Sigma, DMAIC, and statistical process control. Effective collaboration and communication skills across all organizational levels. Preferred Qualifications
Six Sigma or Design for Six Sigma experience. Lean manufacturing experience. Knowledge of GMP and quality/operations systems. Working knowledge of CAD software (SolidWorks, AutoCAD). Other
This position requires up to 20% domestic and international travel. Compensation
Base salary range: $63,000 to $102,350. Benefits
Employees are eligible for medical, dental, vision, life insurance, disability coverage, and group legal insurance. 401(k) and long‑term incentive programs are also available.
Vacation, sick leave, holiday pay, and additional family‑friendly benefits are provided per company policy. Equal Opportunity Employment
Johnson & Johnson is an equal‑opportunity employer. All qualified applicants receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or protected veteran status.
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The Quality Engineer II will supervise, execute, and coordinate quality assurance activities to ensure effective product quality processes throughout the lifecycle of products. The role is pivotal in New Product Development (NPD) teams, supporting design verification, process validation, and qualification activities in compliance with company Quality System policies and applicable regulatory standards. Responsibilities
Work with R&D, Operations, and other functional groups to support new product development, engineering projects, and quality assurance activities. Apply Quality Engineering tools and processes to develop and implement practices that facilitate efficient product and process development and transfer. Lead continuous improvement initiatives for quality and customer satisfaction. Support the Non‑Conformance Report (NCR) process and develop associated risk‑management plans (AFMEA, DFMEA, PFMEA). Write, review, and approve process and product validation protocols, equipment qualifications, and engineering change orders. Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, and improve process capability. Support sterility, biocompatibility, and packaging test requirements per standard operating procedures. Ensure design control requirements are met, including Design Traceability, GSPR compliance, and proper transfer to manufacturing. Conduct technical problem solving, failure analysis, and root‑cause determination. Make independent engineering decisions and represent the organization in technical conferences. Present business‑related issues or opportunities to management. Maintain compliance with all regulatory, company, and ethical policies. Qualifications
Bachelor’s degree in engineering or a scientific field (preferred). Minimum 2 years of quality, manufacturing, or R&D experience in a medical device or regulated industry. Strong analytical skills with ability to define problems, collect data, establish facts, and provide recommendations. Knowledge of regulatory, technical, and business requirements for due diligence assessments. Experience with quality standards implementation and auditing. Proficiency in Design for Six Sigma, DMAIC, and statistical process control. Effective collaboration and communication skills across all organizational levels. Preferred Qualifications
Six Sigma or Design for Six Sigma experience. Lean manufacturing experience. Knowledge of GMP and quality/operations systems. Working knowledge of CAD software (SolidWorks, AutoCAD). Other
This position requires up to 20% domestic and international travel. Compensation
Base salary range: $63,000 to $102,350. Benefits
Employees are eligible for medical, dental, vision, life insurance, disability coverage, and group legal insurance. 401(k) and long‑term incentive programs are also available.
Vacation, sick leave, holiday pay, and additional family‑friendly benefits are provided per company policy. Equal Opportunity Employment
Johnson & Johnson is an equal‑opportunity employer. All qualified applicants receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or protected veteran status.
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