Process Quality Leader

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:
San Lorenzo, Puerto Rico, United States of America

Job Description:

Ethicon LLC is recruiting for a Process Quality Leader position, located in San Lorenzo.

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 

Under the direction of the Business Unit Leader, provides technical leadership towards the identification of the causes for non-conformances and process failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

Key Responsibilities:

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



* Reviews and analyses quality trends with the manufacturing team.

Considering the quality trends provides direction in terms of setting work priorities for process improvement.


* Provides mentorship to manufacturing supervisors to ensure that effective in-depth investigations are performed.


* Provides leadership and mentorship to multifunctional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.

Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.


* Leads investigations of the negative trends and in alignment with the Process Engineer, Quality Engineering, manufacturing, and facilities the implementation process.


* Analysis of data and based on the trends recommends actions for process, equipment and system improvement.


* Writes procedures, protocols and any other Documentation needed for the improvement of processes and systems.


* Provides training and education to the operations team on tools for process evaluation and improvement.

(Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements).


* May lead a number of C...