Supplier Quality Engineer II

About the role

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.
• 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.
• Aid in defining requirements and generating documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs).
• Aid in planning and providing on-site and off-site training to CMs on product inspection and testing.
• Maintain product quality and production rates at CMs and assist in resolving production line issues.

  Requirements

  • 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.
  • Experience with 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 Corrective Action Preventive Action (CAPA) for Non-Conforming Materials; Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks; Good Documentation Practices (GDP); and Metrology and inspection tools (Calipers, MicroVu, Go/No-Go Gages).
  • SolidWorks 2019 Essential Training Certificate Required.
  • Six Sigma and Lean Manufacturing certification preferred.
  • Risk Management Tools (dFMEA, pFMEA) certification preferred.
  • Document Control and Corrective and Preventive Action (CAPA) certification preferred.
  • Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks certification preferred.
  • Statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, and MSA) certification preferred.
  • Process Validation/Equipment Qualification (IQ/OQ/PQ) certification preferred.
  • Root Cause Analysis, Fishbone Diagram, Control Charts and Corrective Action Preventive Action (CAPA) for Non-Conforming Materials certification preferred.
  • Good Documentation Practices (GDP) certification preferred.
  • Metrology and inspection tools (Calipers, MicroVu, Go/No-Go Gages) certification preferred.
  • Lean Six Sigma Green Belt certificate required.