Process Quality Specialist

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:

Business Process Quality

Job Category:

People Leader

All Job Posting Locations:

San Angelo, Texas, United States of America

Job Description:

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Process Quality Specialist to be located in San Angelo, TX.

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/ (https://www.jnj.com/

Under the direction of the Business Unit Manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

•    Leads investigations and rapid response teams (RRT) of the negative trends, quality/product process investigations & product complaints.
•    Provides technical leadership towards the identification of the causes for non-conformances & process' failures, and implementation of the immediate, corrective & preventive actions.
•    Reviews & analyses quality trends with the manufacturing team & provides guidance for process enhancement setting work priorities, effective in-depth investigation.
•    Provides training and education to the manufacturing team on tools for process evaluation and enhancement.
•    Provides guidance to manufacturing supervisors or support groups to ensure that effective in-depth investigations are performed.  
•    Manages all preparation and execution for internal and external audits including audit observations and implementation of corrective actions.
•    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 multiple CAPAs and should recommend CAPAs based on negative trends.
•    Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
•    Responsible for communicating business related issues or opportunities to next management level.
•    For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
•    Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
•    Performs other duties assigned as needed

Experience and Education:
•    Bachelor’s degree is required, Engineering or Science Degree preferred.
•    Requires minimum of four (4) years work experience, with at least two (2) years of experience in the QSR/ISO required - regulated medical device operation preferred
•     Must have thorough knowledge in QSR, GMP, ISO and failure mode analysis techniques and analytical problem solving
•     Requires good negotiation skills.  
•     Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
•    May requires working / visiting all production shifts of the operation and working irregular hours including immediate rapid response to quality situations.
•    Will require sitting for extended periods of time, writing