Supplier Quality Engineer II

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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: A011.10389.2

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 ...