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

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!

Key Responsibilities:

• Provide support in quality improvement opportunities as appropriate to new products, continuous improvement and customer satisfaction.

• Understand the investigation processes related to corrective and preventive action (CAPA) as well as nonconformances (NC), identification of root cause and recommend action(s). Generate nonconformance reports and assist in investigation, final disposition and corrective action.

• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).

• Assign/review quality inspection testing and test data. Communicate activities and issues to supervisor.

• Reviews documents for GDP.

• Support audits.

• Help execute and develop process and product validation/verification protocols and reports, equipment qualifications and engineering change orders.

Qualifications

Education:

• A minimum of a Bachelor’s degree with focus in engineering and/or scientific field is preferred. Alternatively, 2+ years of quality, manufacturing, or research and development experience in a medical device or other regulated industry.

Experience and Skills:

Required:

• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations

• Ability to effectively collaborate and connect with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes

• Ability to function in a team environment and deliver on team objectives

• Strong attention to detail

Preferred:

• Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.

• Developed presentation skills.

• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and AN