Supplier Quality Engineer II- Shockwave Medical

Supplier Quality Engineer II - Shockwave Medical

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- Shockwave Medical role at Johnson & Johnson Med Tech
.

Location:

Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medical to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device 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 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
• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with the 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

Equal Opportunity

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,…