Supplier Quality Engineer II

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Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

Location: Santa Clara, CA, United States of America

Employer: Shockwave Medical, Inc.

Job Title: Supplier Quality Engineer II

Job Code: A011.10389.2

Job Type: Full-Time

Rate of Pay: $170,248 - $171,000 per year

Partner with Procurement, R&D, Operations, Quality, and Suppliers to ensure timely investigation, resolution, and prevention of supplier quality issues that could disrupt business operations. Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to upper management. 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 guiding suppliers through true root cause analysis and implementing corrective and preventive actions. Participate in component qualification and change projects in collaboration with key business partners and the supplier’s functional groups. Compile, analyze, and summarize supplier performance data for Supplier Scorecards. Review, investigate, disposition, and drive to completion of 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 findings. Participate in internal and third‑party audits (e.g., FDA, Notified Body). Participate in Material Review Board (MRB) meetings. 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 resolving production line issues.

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field and at least 3 years of experience in the role offered or in a Supplier Quality Engineer II‑related occupation.

• Medical device industry
• Quality Systems, including cGMP, FDA 820 QSR and ISO 13485
• Statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, and MSA)
• Six Sigma and Lean Manufacturing
• Process Validation/Equipment Qualification (IQ/OQ/PQ)
• Risk Management Tools (dFMEA, pFMEA)
• Root Cause Analysis, Fishbone Diagram, Control Charts and CAPA for Non‑Conforming Materials
• Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using Solid Works
• Good Documentation Practices (GDP)
• Metrology and inspection tools (Calipers, Micro Vu, Go/No‑Go Gages)

Lean Six Sigma Green Belt certificate required.

SOLIDWORKS 2019 Essential Training Certificate required.

This position is anticipated to close on 8/16/2026.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time‑off benefits:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hours for…