Senior Quality Engineer NPD

Johnson Johnson; Irvine (CA); On-site; USD 120,000 - 165,000; Full time

Job summary

Johnson & Johnson Irvine site is seeking a Senior Quality Engineer to plan, coordinate, and execute quality assurance activities across the product lifecycle. You’ll participate in New Product Development teams, lead quality engineering efforts, and ensure compliance with company policies and external standards.

The role requires SME-level knowledge of quality tools, process validation, risk management, and statistical analysis, with opportunities to drive improvements and robust quality systems.

Qualifications

• Senior Quality Engineer directs QA activities across product lifecycles.
• Acts as SME on quality topics and tools.
• Supports NPD teams, design verification, and validations.
• Includes risk management, FMEA, and DOE analyses.

Responsibilities

• Collaborate with R&D and Operations to support NPD.
• Oversee NCR process from a Quality NPD perspective.
• Develop QC plans, risk management, and PFMEA/DFMEA.
• Write/approve validation protocols and equipment qualifications.
• Apply SPC, Six Sigma, ANOVA and Gauge R&R analyses.

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

The Senior Quality Engineer - plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.

SECTION 2: DUTIES & RESPONSIBILITIES*

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.

Additional Duties:

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who su