Senior 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:
Customer/Commercial Quality

Job Category:
Professional

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

Job Description:

Johnson & Johnson is hiring for a Sr.

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 & ISO regulations, the Quality Systems Specialist will perform work under general supervision.

The general scope of this position is to assist in maintaining quality compliance, managing new geographies Quality Compliance Assessments, managing actions for the audit findings and CAPAs, assisting with External Standards management process, supporting audit activities and compiling quality metrics.

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

Essential Job Functions


* Assist in managing audit findings and CAPA actions


* Assist in managing overall compliance of the CAPA and audit systems


* Work cross-functionally with other teams to track and manage Audit findings and CAPA activities from initiation through closure


* Identify and implement CAPA and audit system continuous improvement activities


* Assist with audit preparation activities, conduct a...