Job Posting Title Staff Quality Engineer - Escalations

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:
Ciudad Juarez, Chihuahua, Mexico, São José dos Campos, São Paulo, Brazil

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States and Puerto Rico- Requisition Number: R-005177

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Staff Quality Engineer – Escalations role.

The Staff Quality Engineer is responsible for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management and quality review boards to inform and support decisions to initiate field actions when appropriate.

Key Responsibilities:


* Execute and lead all associated activities related to the product risk escalation/assessment process to ensure compliance with internal and external requirements.


* Execute the overall escalation process from issue identification to presentation at the Risk Management Board (RMB) as well as the Quality Review Board (QRB), when required.


* Collect, create and review escalation documentation to ensure robustness and compliance.


* Prepare meeting content to the Risk Management Board and/or Quality Review Board to help facilitate the determinations of field actions and run the escalation meetings at the Risk Management Boards.


* Appropriately utilize risk management within the escalation process.


* Partner with Quality Operations, Compliance, Regulatory, R&D, Medical Safety, as well as other organizations who may own portions of a given product issue escalation.


* Provide periodic reports, presentations, and metrics related to product risk escalations to upper management as needed.


* Aspire to and effectively cal...