Document Control Specialist II - 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 Document Control Specialist II – 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

In compliance with FDA, European MDD/MDR & ISO regulations, the Document Control Specialist II will perform work exercising judgment with only general supervision.

General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SWMI.

This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions


* Maintain the change control process via engineering change control system (log, track and process changes, maintain material item data, and BOM data)


* Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards


* Review, process, and release documents using variety of software packages.


* Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files)


* Maintain controlled access to master files and archived documents on Shockwave Medical’s system and/or shared servers


* Assist in the data entry of employee training records when needed


* Assist maintenance of Direct Labor Competency Assessment Records when needed


* Support Regulatory Assurance by assisting backroom activities during audits


* May support periodic departmental audits to assure that the appropri...