Sr. Supplier Quality Engineer- Shockwave Medical

This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Med Tech, 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

Job Function:
Supply Chain Engineering

Job Sub     Function:
Quality Engineering

Job Category:
Scientific/Technology

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

Job Description:

Johnson & Johnson is hiring for a  Sr. Supplier Quality Engineer - Shockwave Medica l 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 Med Tech, 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
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 Sr. Supplier Quality Engineer performs work with general supervision to provide and implement solutions to broad problems and accomplishes complex assignments.  The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues.  The Sr. Supplier Quality Engineer participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.
Essential Job Functions
Supplier Management
Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
Plan, schedule, execute, report, and follow-up on supplier audits
Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
Own, manage, and drive to completion Supplier Change Assessments (SCAs)
Participate in component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups
Compile, analyze, and summarize supplier performance data for periodic management reviews
Manufacturing Support
Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
Initiate, review, and approve Document Change Orders (DCOs)
Provide technical support and guidance to the Quality Assurance group
Support internal and third-party audits (FDA, Notified Body)
Participate in Material Review Board (MRB) meetings
Manufacturing Line Transfers
Partner with cross-functional teams to define requirements and generate…