Senior Quality Engineer NPD (1 of 2)

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:

Johnson & Johnson is recruiting for a Senior Quality Engineer NPD to be located in Irvine, CA.

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.

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.


* 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 val...