Katalysthealthcareslifesciences

Supplier Quality Engineer

Sunnyvale, CA, United States · Junior

Sponsorship not specifiedDetected 359 days ago
Project ManagementNegotiationExcelAuditingProcess ImprovementERPClinical TrialsClinical ResearchPharmacovigilanceMedical DevicesResearchCommunicationProblem SolvingPublic Speaking

About the role

  • All your information will be kept confidential according to EEO guidelines.

Responsibilities

  • Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability.
  • Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
  • Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.

Requirements

  • Excellent knowledge of 21
  • Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.
  • Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.

Nice to have

  • Practical knowledge of PFMEA's and process validations.
  • Ability to read and interpret detailed mechanical drawings and communicate technical information.
  • Excellent problem solving and project management skills.
  • Excellent written and verbal communication skills including presentations to executive level management.
  • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
  • Practical knowledge of part production qualification process.
  • Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP.
  • CAD experience with 3D modelling tools is a plus.
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