Lead Quality Engineer - MedTech NPD & Validation

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

Benefits offered by this job

Pension plan

401(k) savings plan

Paid vacation

Job summary

Johnson & Johnson MedTech in Irvine, CA is seeking a Staff Quality Engineer to lead quality assurance activities across the product lifecycle and participate in New Product Development teams. You will act as a SME on quality tools, drive risk management, design verification, and process validation to ensure compliance with Quality System policies.

The role requires strong leadership, collaboration with R&D and Operations, and the ability to mentor other engineers while upholding GMP and

Qualifications

• Bachelor’s degree in engineering or scientific discipline required.
• Master’s degree preferred.
• Minimum 6 years in quality, manufacturing, or R&D in a regulated medical device environment.

Responsibilities

• Lead quality assurance activities across product lifecycle and NPD teams.
• Develop and apply QA tools, process validations, and risk management plans.
• Write and review validation protocols, reports, and change orders.
• Use Six Sigma/DOE/ SPC methods to analyze data and improve process capability.
• Mentor engineers and collaborate with Design/Regulatory/Operations teams.

Skills

Quality leadership

Statistical analysis

Problem solving

Cross-functional collaboration

Education

Bachelor's degree

Master's degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson MedTech in Irvine, CA is seeking a Staff Quality Engineer to lead quality assurance activities across the product lifecycle and participate in New Product Development teams. You will act as a SME on quality tools, drive risk management, design verification, and process validation to ensure compliance with Quality System policies.

The role requires strong leadership, collaboration with R&D and Operations, and the ability to mentor other engineers while upholding GMP and