Senior Quality Engineer, NPD Lead

Johnson & Johnson Innovation; Irvine (CA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson Innovation seeks a Senior Quality Engineer to plan and drive quality assurance across the product lifecycle at its Irvine, CA site. You will partner with R&D and Operations on NPD projects, develop QMS plans, and ensure compliance with MDR/GSPR and design controls.

The role emphasizes leadership in quality engineering, problem solving, and collaboration across teams to deliver compliant medical devices.

Qualifications

• Bachelor’s degree in engineering or scientific discipline.
• 4+ years of quality, manufacturing, or R&D in medical device or regulated industry.
• Knowledge of design control, V&V, GMP and regulatory requirements.
• Auditing, problem-solving and data-driven decision making.

Responsibilities

• Plan, coordinate, and execute quality assurance activities across product lifecycle.
• Lead NPD quality work, design verification tests, and validation protocols.
• Develop quality control and risk management plans (FMEA, DFMEA, PFMEA).
• Apply Six Sigma, SPC, and DOE to analyze data and improve processes.
• Ensure design controls, MDR/GSPR compliance, and smooth transfers to manufacturing.
• Collaborate with R&D and Operations to support development projects.

Skills

Problem solving

Regulatory & compliance

Project management

Quality standards

DOE / DOE tools

GMP knowledge

CAD (SolidWorks)

AutoCAD

Minitab / R

GD&T

Education

Bachelor’s degree in Engineering or Science

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson Innovation seeks a Senior Quality Engineer to plan and drive quality assurance across the product lifecycle at its Irvine, CA site. You will partner with R&D and Operations on NPD projects, develop QMS plans, and ensure compliance with MDR/GSPR and design controls.

The role emphasizes leadership in quality engineering, problem solving, and collaboration across teams to deliver compliant medical devices.