GSC Quality Systems 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:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:

JOB SUMMARY

You will be reporting to the GSC Quality Systems & Compliance Leader where your primary purpose is to:


* Support the execution of the DePuy Ireland’s Quality Management System Processes


* Deliver support to GSC projects from a quality point of view.

Drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements

DUTIES & RESPONSIBILITIES


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


* Drives compliant execution of the following for their assigned processes and projects


* Manages specified quality system processes.


* Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements.


* Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner


* Compiles, contextualizes, evaluates, and presents Quality Systems data and metrics for all metric review meetings.


* Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.


* Understands and uses data, key metrics and statistical methods, quality tools or computer-based solutions to improve processes


* Responsible for identifying and communicating the need for process improvement opportunities to responsible management.


* Identifies personnel that require training on the relevant processes and rolls out training as required


* Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes.

Lead and drive improvements as required


* Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.


* Supports the assigned processes during internal and external audits.


* Acts as Stop Shipment Coordinator for Joint Reconstruction QA MAKE o...