J&J Staff Quality Engineer NPD – Johnson & Johnson, Irvine, California, USA

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
Application Deadline: October 15, 2026, subject to extension
Official Website: https://careers.jnj.com/

Job Overview

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.

About Johnson & Johnson

Johnson & Johnson is a global healthcare company operating through its Innovative Medicine and MedTech 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.

Key Responsibilities of the Staff Quality Engineer NPD

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, biocompatibility, and packaging testing requirements for new products.
• Ensuring compliance with design control requirements, design traceability matrices, applicable product standards, and relevant General Safety and Performance Requirements (GSPR) under the EU Medical Device Regulation (MDR), as applicable.
• Supporting the transfer of new products and processes to manufacturing in accordance with approved specifications.
• Conducting technical problem-solving, failure analysis, and root cause investigations.
• Evaluating engineering tests, proposed products, and equipment to determine technical feasibility and suitability.
• Coordinating project milestones and recommending solutions for significant quality, process capability, and compliance issues.
• Providing technical guidance and mentoring to quality engineers and other team members.

The role may also require leading complex engineering projects, communicating significant business or compliance concerns to management, and ensuring adherence to company health, safety, environmental, and regulatory policies.

Educational Qualifications

Applicants must have a bachelor’s degree, preferably in engineering or a relevant scientific discipline. A master’s degree is preferred.

Candidates with academic backgrounds in biomedical, mechanical, electrical, chemical, industrial, or other relevant engineering disciplines may be well suited to the role, subject to the employer’s assessment of their qualifications and experience.

Experience Requirements

A minimum of six years of experience in quality, manufacturing, or research and development within the medical device industry or another regulated industry is required.

Relevant experience may include:

• Quality assurance and quality engineering.
• New product development and design controls.
• Process validation and equipment qualification.
• Risk management and failure investigation.
• Statistical analysis and process improvement.
• Medical device manufacturing and quality management systems.
• Regulatory compliance, auditing, and corrective and preventive action management.
• Technical project leadership and employee mentoring.

Candidates should demonstrate the ability to work independently on complex technical problems and collaborate effectively with multidisciplinary teams.

Required Knowledge and Technical Skills

The ideal candidate should possess strong analytical, technical, communication, and leadership skills. The employer identifies several important areas of knowledge and experience, including:

• Quality engineering methodologies and design control.
• Verification and validation (V&V) tools and techniques.
• Corrective and Preventive Action (CAPA).
• Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).
• Statistical methods, including DOE, DMAIC, ANOVA, and process capability analysis.
• Six Sigma, Design for Six Sigma, and Lean manufacturing.
• Auditing, risk assessment, and compliance management.
• Project management and cross-functional collaboration.
• Team leadership, mentoring, and developing other employees.
• Quality standards, Standard Operating Procedures (SOPs), and fact-based decision-making.

Knowledge of CAD software such as SolidWorks or AutoCAD is an advantage. Experience with Minitab, R, and other statistical software is also beneficial. Familiarity with Geometric Dimensioning and Tolerancing (GD&T) and ASME Y14.5 is considered useful.

Salary and Benefits

The advertised anticipated annual base salary range for this position is:

$94,000 to $151,800 per year.

The final compensation may depend on relevant experience, qualifications, work location, and applicable company policies.

According to the supplied job description, eligible employees may participate in the company’s consolidated retirement plan, including pension and 401(k) savings arrangements, subject to the applicable plan terms. The position is also eligible for participation in the company’s long-term incentive program, subject to the relevant terms and conditions.

Applicants should consult the official vacancy for further information regarding the complete compensation and benefits package.

Job Location and Work Pattern

The position is based in Irvine, California, United States, and follows a hybrid work pattern. Candidates should confirm the specific on-site and remote working expectations with the employer during the recruitment process.

How to Apply for the J&J Staff Quality Engineer NPD Job

Interested candidates can apply through the official Johnson & Johnson careers portal.

Application steps:

1. Visit https://careers.jnj.com/.
2. Search for the job title Staff Quality Engineer NPD.
3. Look for requisition number R-102177.
4. Review the complete job description and confirm that you meet the educational and experience requirements.
5. Prepare an updated resume highlighting new product development, quality engineering, risk management, validation, statistical analysis, and leadership experience.
6. Submit your application through the official careers portal while the vacancy remains open.

Application deadline: October 15, 2026. The company may extend the closing date, so candidates should check the live advertisement for current availability.

Frequently Asked Questions (FAQs)

1. What is the job title?

The position is Staff Quality Engineer NPD at Johnson & Johnson in Irvine, California, USA.

2. What is the minimum experience required?

Candidates must have at least six years of experience in quality, manufacturing, or research and development in a medical device or another regulated industry.

3. What is the salary for this position?

The advertised annual base salary range is $94,000 to $151,800, subject to the employer’s compensation policies and applicable conditions.

4. Is a master’s degree compulsory?

No. A bachelor’s degree is required, preferably in engineering or a scientific discipline. A master’s degree is preferred.

5. What is the application deadline?

The anticipated closing date is October 15, 2026. The employer may extend the recruitment period.

6. How can candidates apply?

APPLY NOW

Candidates can search for requisition R-102177 on the official Johnson & Johnson careers website: https://careers.jnj.com/.

Disclaimer: This job post is prepared from the vacancy information supplied for Pharmaguidances. Candidates should verify the latest availability, requirements, salary, and application conditions on the official Johnson & Johnson careers website before applying.

Stay connected with Pharmaguidances for the latest pharmaceutical, medical device, quality assurance, quality control, regulatory affairs, and healthcare industry job updates.