Quality Engineer NPD
Listed on 2026-01-02
-
Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
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 Med Tech, 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
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:
About Med Tech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at
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 Med Tech, 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
We are searching for the best talent for Quality Engineer I NPD to work onsite at Irvine, CA.
Under general supervision, the Quality engineer I participates in new and sustaining product/process teams to support design verification tests, process validations, quality processes. 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 work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Will receive technical guidance on sophisticated problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion.
Carries out calculations and documents test results. Writes and/or reviews technical reports, develops charts, graphs, schematics and drawings to illustrate improvement processes. Ensures tools and test equipment are properly calibrated and repaired. Makes recommendations on improving quality, efficiency, cost of company product(s), processes, and/or efficiency techniques. Ensures all documentation is recorded properly and follows procedures.
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.
- Leading efforts for continuous quality and customer satisfaction improvement opportunities.
- Support 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.).
- 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…
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