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:

Employer: Shockwave Medical, Inc.

Job Title: Supplier Quality Engineer II

Job Code:

Job Location: Santa Clara, CA

Job Type: Full-Time

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

Job Duties: 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 the next level of 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 applicable functional groups. Compile, analyze, and summarize supplier performance data for Supplier Scorecards. 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 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.

Requirements: Employer will accept a Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering or related field and 3 years of experience in job offered or in a Supplier Quality Engineer II-related occupation.

Position requires experience with:

1. Medical device industry;

2. Quality Systems, including cGMP, FDA 820 QSR and ISO 13485;

3. Statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, and MSA);

4. Six Sigma and Lean Manufacturing;

5. Process Validation/Equipment Qualification (IQ/OQ/PQ);

6. Risk Management Tools (dFMEA, pFMEA);

7. Root Cause Analysis, Fishbone Diagram, Control Charts and Corrective Action Preventive Action (CAPA) for Non-Conforming Materials;

8. Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks;

9. Good Documentation Practices (GDP); and

10. Metrology and inspection tools (Calipers, MicroVu, Go/No-Go Gages).

Lean Six Sigma Green Belt certificate required.

SOLIDWORKS 2019 Essential Training certificate required.

This job posting is anticipated to close on 8/16/2026.

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

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; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Required Skills:

Preferred Skills: