Staff Quality Engineer – NPD Leader

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

Benefits offered by this job

Vacation leave

Sick leave

Holidays

Parental leave

Bereavement leave

Volunteer leave

Military Spouse time-off

401(k) plan

Job summary

Johnson & Johnson in Irvine, CA, seeks a Staff Quality Engineer to lead QA activities across new product development and lifecycle management. You will drive quality processes, develop risk management plans, and mentor engineers while partnering with R&D and operations to ensure compliance with GMP/QMS.

The role requires a strong background in quality engineering, CAD tools, and statistics, with a focus on process validation and continuous improvement in a regulated medical device environment.

Qualifications

• Bachelor’s degree in engineering or science; Master’s preferred.
• 6+ years in quality, manufacturing, or R&D in regulated industry.
• Knowledge of GMP and QMS.
• CAD and statistical software experience (e.g., SolidWorks, Minitab).
• Strong problem solving and leadership capabilities.

Responsibilities

• Lead QA activities across NPD and lifecycle.
• Develop QC plans, risk management, and DOE/DFMEA/PFMEA.
• Use statistical tools (Six Sigma, SPC) for decisions.
• Oversee NCR processes and validation protocols.
• Mentor QA team and collaborate with design and operations.

Skills

Leadership

Quality engineering

CAPA

Cross-Functional

SOP

Risk assessments

Education

Bachelor’s degree

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson in Irvine, CA, seeks a Staff Quality Engineer to lead QA activities across new product development and lifecycle management. You will drive quality processes, develop risk management plans, and mentor engineers while partnering with R&D and operations to ensure compliance with GMP/QMS.

The role requires a strong background in quality engineering, CAD tools, and statistics, with a focus on process validation and continuous improvement in a regulated medical device environment.