Staff Quality Engineer — Lead NPD & Quality

Johnson & Johnson Innovative Medicine; Irvine (CA); On-site; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Irvine, CA seeks a Staff Quality Engineer to lead QA activities across the product lifecycle, support NPD teams, develop quality systems, and drive compliant solutions in a complex medical device environment.

You will mentor engineers, apply Six Sigma, DFMEA, PFMEA, and DOE methods, and collaborate with R&D and Operations to ensure product quality while meeting regulatory standards.

Qualifications

• Bachelor’s degree in engineering or science.
• Minimum 6 years in quality, manufacturing, or R&D in medical devices.
• Six Sigma or Design for Six Sigma experience.
• Lean manufacturing experience.
• Auditing and problem-solving skills.

Responsibilities

• Lead quality assurance activities across the product lifecycle.
• Collaborate with R&D and Operations on new product development.
• Apply quality tools to develop, transfer, and maintain products/processes.
• Develop risk management plans and design controls.
• Write and review validation protocols and reports.

Skills

Problem solving

Data analysis

Leadership

Communication

Education

Bachelor’s degree

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson Innovative Medicine in Irvine, CA seeks a Staff Quality Engineer to lead QA activities across the product lifecycle, support NPD teams, develop quality systems, and drive compliant solutions in a complex medical device environment.

You will mentor engineers, apply Six Sigma, DFMEA, PFMEA, and DOE methods, and collaborate with R&D and Operations to ensure product quality while meeting regulatory standards.