Quality Records Manager - 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:
Professional

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

Job Description:

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

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/.

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 Records Manager develops and implements strategies to ensure accurate, secure, and compliant management of organizational records throughout their lifecycle, from creation to disposal.

Responsibilities include establishing record-keeping systems, ensuring compliance with regulations, managing electronic and physical records, training staff, and maintaining data integrity and accessibility for the organization. 

Essential Job Functions


* Policy Implementation: Implement records management policies, procedures, and systems to ensure compliance with regulatory requirements and best practices. 


* Records Lifecycle Management: Oversee the management of records from their creation and classification through their use, storage, retention, and final disposal or archiving. 


* Compliance: Conduct regular monitoring of records management practices to ensure adherence to established policies and identify areas for improvement. 


* Data Security and Integri...