Quality Engineer 1 NPD

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 https://www.jnj.com

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 MedTech

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 https://www.jnj.com/medtech

#Li-Hybrid

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Quality Engineer 1 NPD to be in Irvine, California.

The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in 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 in developing quality-engineered systems and products, and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. 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. If you are an individual who enjoys working with the other team members and changing the lives of our patients around the world, come join our team!

SECTION 1: JOB SUMMARY

Under general supervision, participate 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.

SECTION 2: DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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.