Quality Operations Lead

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 Assurance

Job Category:
People Leader

All Job Posting Locations:
Irving, Texas, United States of America

Job Description:

Johnson and Johnson is recruiting for a Quality Operations Lead located in Irving, TX.

Leads Quality Operations group to ensure that performance and quality of products conform to established company and regulatory standards.  Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards.  Establishes and maintains quality assurance programs, procedures, and controls.  

DUTIES & RESPONSIBILITIES:

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


* Responsible for oversighting quality engineering group in collaboration with other functional areas to ensure effective & efficient manufacturing operation. 



* Ensures that performance and quality of products conform to established company and regulatory standards. 



* Oversight the nonconformance process in collaboration with operations including verification of bounding, disposition of non-conforming material, verification of corrective action or effectiveness check where applicable 



* Advises staff to help meet established operational schedules translated from goals & objective or resolve technical or operational problems.  



* Formulates and maintains quality assurance objectives and coordinates objectives in cooperation with other manufacturing managers to maximize product reliability and minimize defects/costs.  



* Determines improvement direction or product line modifications to drive proactive quality which include data evaluation/monitoring against risks, drive cost/quality improvement project, ensure effective implementation/error remediation in production related system/databases. 



* Overall driver of CAPA process which includes but not limited to: identification process/system gaps, reviewing investigation report findings, make recommendation for corrective action, ensure effective implementation of CAPA, and verification of effectiveness.  



* Provides Data Analysis, trending and potential gaps with proper risk analysis for Management Review including monitoring key quality performance measures and corrective action results.  Assess use o...