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:
Manatí, Puerto Rico, United States of America, San Lorenzo, Puerto Rico, United States of America

Job Description:

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:


* Dedicated to developing, manufacture, and market quality products.


* Reviews and analyses quality trends with the manufacturing team.

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


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


* Provides leadership and guidance to cross functional, 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 and the Manufacturing Manager, 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 enhancement of processes and systems.


* Provides training and education to the manufacturing team on tools for process evaluation and enhancement.

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


* May lead a number of CAPA and should recommend CAPA’s based on negative trends.


* Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB.


* Leads in-process investigations with a multifunction team to determine root causes and provides recommendations for corrections on preventive actions.


* Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventive actions.


* Provides technical supervision to multilevel, cross functional teams.

Provides supervision to technical professionals such as Process Quality Technicians, College Recruits, C...