Staff Quality Engineer - NPD Leader

jj; Irvine (CA); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Long-term incentive

Paid time off

Job summary

Johnson & Johnson Irvine seeks a Staff Quality Engineer to lead quality assurance activities for medical devices, from NPD through lifecycle, ensuring compliance with Quality System policies and standards. You will work with R&D and operations, apply statistical tools, and mentor teams to deliver robust quality processes, with opportunities to drive continuous improvement and risk management.

This role requires a Bachelor's in engineering, 6+ years in quality, and a passion for compliant

Qualifications

• Bachelor’s degree in engineering or a scientific field.
• Master’s degree preferred for advanced roles.
• Minimum 6 years of quality, manufacturing, or R&D experience in a regulated medical device setting.

Responsibilities

• Lead quality assurance activities across product lifecycles.
• Develop and approve validation protocols and reports.
• Apply Six Sigma, SPC, DOE to improve processes.
• Mentor engineers and coordinate with R&D and operations.
• Manage risk assessment and design control documentation.

Skills

Quality engineering

Statistical analysis

Design control

Six Sigma

DOE

Leadership

Education

Bachelor’s degree in engineering or scientific field

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson Irvine seeks a Staff Quality Engineer to lead quality assurance activities for medical devices, from NPD through lifecycle, ensuring compliance with Quality System policies and standards. You will work with R&D and operations, apply statistical tools, and mentor teams to deliver robust quality processes, with opportunities to drive continuous improvement and risk management.

This role requires a Bachelor's in engineering, 6+ years in quality, and a passion for compliant