Staff Quality Engineer — Lead QA for Medical Devices

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

Benefits offered by this job

Vacation time

Sick time

Parental Leave

Holidays

Job summary

Johnson & Johnson is seeking a Staff Quality Engineer in Irvine to lead quality assurance activities, guide NPD teams through design verification and validation, and ensure compliance with MDR and ISO standards. The role requires hands-on leadership and deep QA expertise.

The ideal candidate will drive risk management, validation testing, and cross-functional collaboration with R&D and operations. This position offers a comprehensive benefits package and a dynamic work environment.

Qualifications

• Bachelor’s degree in engineering or science (required).
• Master’s degree preferred.
• Minimum 6 years of quality, manufacturing, or R&D experience in medical devices or regulated industries.

Responsibilities

• Lead quality assurance activities across the product lifecycle.
• Support NPD teams with design verification, testing, and process validation.
• Develop risk management plans and QA documentation core to programs.
• Use statistical tools to analyze data and improve process capability.
• Mentor other quality engineers and collaborate with design teams.

Skills

Quality Engineering

Project management

Auditing

Design of Experiments

CAPA

GD&T

Lean manufacturing

Six Sigma

Cross-functional collaboration

Leadership

Education

Bachelor’s degree

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson is seeking a Staff Quality Engineer in Irvine to lead quality assurance activities, guide NPD teams through design verification and validation, and ensure compliance with MDR and ISO standards. The role requires hands-on leadership and deep QA expertise.

The ideal candidate will drive risk management, validation testing, and cross-functional collaboration with R&D and operations. This position offers a comprehensive benefits package and a dynamic work environment.