Principal Quality Compliance Software 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 Compliance Software 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

The Principal Quality Compliance Software Specialist supports Shockwave Medical’s process for non-product software development life cycle (SDLC) including associated procedures for non-product software compliance assessments and validation of non-product software, ensuring compliance with regulatory requirements and industry standards.

Supports project plans as QA representative when cross-functional support is needed.

Leads/supports collaboration with various functional areas, partners with colleagues across Shockwave sites, to ensure GxP compliance for non-product software applications are established and maintained.

Supports establishing and maintaining the validation master plan for non-product software applications for Shockwave.  

Serves as Shockwave’s non-product software SME and supports Shockwave sites in this role, as needed.

Provides support to quality system, quality system initiatives and audits of quality system.

Provide support for the inves...