Quality Training Coordinator I - Shockwave Medical

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 Documentation

Job Category:
Business Enablement/Support

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Quality Training Coordinator – Shockwave Medical to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Quality Training Coordinator is responsible for managing and maintaining Shockwave Medical’s Quality Management System training program in accordance with FDA, European MDD/MDR, and ISO regulations.

This position works with all levels of the organization and requires excellent written and verbal communication.

Must be able to organize and process training records in both paper and electronic formats.

Essential Job Functions


* Coordinate with hiring managers to setup training sets for new hires that may include technical and Quality Management System procedures


* Work with Manufacturing to maintain Direct Labor training and certification records


* Work with department heads to review and maintain minimum training requirements by function and title (Training Plans)


* Manage training tasks for employees on extended leave


* Mentor and train employees on how to use the QMS training system


* Monitor and send out past due training notifications


* Maintain and prepare training metrics to present at Management Review


* Ensure suppliers are properly trained to applicable procedures before coming on-site to perform work


* Maintain hard copy training records and send to off-site storage for archiving as needed


* Identify and drive improvements to the Training process


* Support and perform Document Control duties as backup as required


* Support Internal audits and third-party audits from regulatory agencies as the subject matter ex...