Supplier Quality Engineer II- Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Johnson & Johnson is hiring for a Supplier Quality Engineer II 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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 suppliers 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 lines to Contract Manufacturers (CMs)
• Assist in planning and providing on-site and off-site training to CMs on product inspection and testing
• Monitor product quality and production rates at CMs and assist in the resolution of production line issues
• Requirements J&J Credo: Understands and applies Johnson & Johnsons Credo and Leadership Imperatives in day-to-day interactions with team.
• Other duties as assigned

Qualifications

• BS degree in a related engineering discipline and 3 years of related experience or
• MS degree in a related engineering discipline
• Experience in the medical device industry is strongly preferred
• Knowledge of cGMP FDA 820 QSR ISO 13485 or other Quality Systems
• Strong technical writing skills
• Effective communication skills across all levels of the organization
• Must be proactive self-motivated and able to work independently with minimal supervision
• Ability to work independently in a fast-paced environment while managing multiple priorities
• Knowledge of statistics (hypothesis testing capability analysis DOE MSA) Six Sigma Lean
• Certifications (CQE Lead Auditor Six Sigma Project Management) would be a plus
• Ability to travel up to 10% of the time

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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