Supplier Quality Engineer II- 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 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  
** Supplier Quality Engineer II - 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 Supplier Quality Engineer II performs work with general supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Supplier Quality Engineer II 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

+ Participate in the planning, scheduling, execution, and reporting of supplier audits

+ Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)

+ Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions

+ 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 Supplier Scorecards

_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 Control group

+ Collaborate with Manufacturing Engineering on process improvement projects

+ Investigate customer complaints and document investigation findings

+ Participate in internal and third-party audits (FDA, Notified Body)

+ Participate in Material Review Board (MRB) meetings

_Manufacturing Line Transfers_

+ Assist in defining requirements and generating documentation for the transfer of manufacturing…