Principal Quality Systems Specialist - 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 Assurance

Job Category:
Professional

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

Job Description:

Johnson & Johnson is hiring for a Principal Quality Systems Specialist – 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

In compliance with FDA, European MDD/MDR & other International Regulations, the Principal Quality Systems Specialist will perform work under minimal supervision.

General scope of this position is to support CAPA, data analysis and continue improvements, support Quality system processes, internal and external audits, support External Standards management process and monitoring or key process metrics.

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

 Essential Job Functions


* Assist in developing, administering, and maintaining quality system procedures and activities to ensure that the SWMI processes and products follow applicable quality standards and requirements


* Participate in external and internal inspections/audits, assist in preparing, conducting the audits and following up on the audit findings.

Assist in maintaining a constant state of inspection readiness


* Identify and process p...