Staff Quality Systems Engineer

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:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America, Plymouth, Minnesota, 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

This is a hybrid role available in United States.

While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application.

We invite candidates from any location to apply.

We are searching for the best talent for Staff Quality Systems Engineer to be located in Irvine, CA or Plymouth, MN.

The Staff Quality Engineer provides high performance quality systems guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system.

This position will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing QSMR Activities, CAPA, NC, product related Escalations, and Field Corrective Actions (FCA).

The QS Engineer will collaborate closely with business partners to provide leadership with regard to Quality System standardization and execution activities to ensure activities are compliant with MD&D Sector, J&J Enterprise Standards and Quality Systems related training.

You will be responsible for:


* Serve as Quality Systems subject matter expert.


* Oversees Quality System metrics and coordinates efforts to maintain a healthy quality system performance.


* Track and report action plan status/completion as it relates to quality system improvement efforts.


* As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation.


* While responsible for CAPA and NC systems, the QS Engineer monitors, and reports Quality Management System metrics to include supporting the Quality System Management Review and QPR.


* Can be assigned as Franchise site lead for CAPA and Non-conformance.


* Coordinate product issue assessments and Field Action execution.


* Lead Quality System Management Review process for either Site or Franchise level


* Works on complex inves...