Supplier Quality Engineer II
$170,248–$171,000 year
On-siteSanta Clara, California, United States
Job Summary
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 management. Participate in the planning, scheduling, execution, and reporting of supplier audits, while initiating, reviewing, and approving Supplier Corrective Action Reports (SCARs). Drive corrective actions by guiding suppliers through root cause analysis and implementing preventive measures. Compile supplier performance data for Scorecards and review, investigate, and drive completion of Non-Conforming Reports (NCRs) and CAPAs. Provide technical support to Quality Control, collaborate on process improvement projects, and assist in defining requirements for transferring manufacturing lines to Contract Manufacturers. Investigate customer complaints, participate in internal and third-party audits, and assist in training CMs on product inspection and testing.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering or related field
- 3 years of experience in job offered or in a Supplier Quality Engineer II-related occupation
- experience with Medical device industry
- experience with 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 Corrective Action Preventive Action (CAPA) for Non-Conforming Materials
- Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks
- Good Documentation Practices (GDP)
- Metrology and inspection tools (Calipers, MicroVu, Go/No-Go Gages)
- Lean Six Sigma Green Belt certificate
- SOLIDWORKS 2019 Essential Training certificate
- Santa Clara, CA
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