Quality Engineer NPD – Johnson & Johnson

Company: Johnson & Johnson (J&J)
Job Title: Staff Quality Engineer NPD
Job Function: Quality
Sub Function: Quality Assurance
Job Category: Senior Supervisor, Quality Assurance (PL6)
Location: Irvine, California, USA
Work Pattern: Hybrid Work
Date Posted: October 1, 2026
Requisition Number: R-102177
Required Experience: Minimum 6 years
Qualification: Bachelor’s degree required; master’s degree preferred
Salary Range: $94,000–$151,800 per year
Final date to receive applications: October 15, 2026, subject to extension
Official Website:

Johnson & Johnson (J&J) is inviting applications for the position of Staff Quality Engineer NPD at its Irvine, California, USA location. This opportunity is suitable for experienced quality professionals with a background in medical devices or other regulated industries, particularly those with expertise in new product development, design controls, risk management, process validation, and quality engineering.

The J&J Staff Quality Engineer NPD position involves leading and coordinating quality assurance activities throughout the product lifecycle. The successful candidate will work closely with research and development (R&D), manufacturing operations, engineering, and other cross-functional teams to ensure that new products meet company quality requirements and applicable regulatory standards.

The role also involves technical problem-solving, product verification and validation, statistical analysis, and the development of effective quality systems. Candidates with strong leadership skills, experience in quality engineering tools, and the ability to mentor other engineers may find this an excellent opportunity to advance their careers in the medical technology industry.

Johnson & Johnson is a global healthcare company operating through its Innovative Medicine and Med Tech businesses. The company focuses on healthcare innovation, developing solutions intended to improve patient outcomes and address complex medical needs.

Quality assurance and quality engineering are essential to the development of safe, effective, and reliable medical technologies. Through design controls, risk management, verification and validation, and manufacturing process oversight, quality professionals help ensure that products meet established specifications and regulatory requirements.

The selected candidate will be responsible for planning, coordinating, and supervising quality engineering activities associated with new product development and lifecycle management.

Key responsibilities include:

• Collaborating with R&D, manufacturing operations, and other functional teams to support new product development and engineering projects.
• Implementing quality engineering practices throughout product development, transfer, and lifecycle management.
• Leading continuous improvement initiatives for existing products, manufacturing processes, and customer satisfaction.
• Overseeing the Non-Conformance Report (NCR) process from a new product development quality perspective for applicable BWI facilities in the United States.
• Developing and maintaining risk management documentation, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and other relevant risk assessments.
• Writing, reviewing, and approving process and product validation protocols, validation reports, equipment qualification documents, and engineering change orders.
• Applying statistical tools such as Statistical Process Control (SPC), Design of Experiments (DOE), Six Sigma, Gauge R&R, and Analysis of Variance (ANOVA).
• Supporting sterility,…