Sr. Supplier Quality Engineer
Electrochem - Beaverton, OR

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Electrochem, a subsidiary of Greatbatch, Ltd, is seeking a Sr. Supplier Quality Engineer. Electrochem specializes in customized rechargeable and non-rechargeable battery cells, battery packs, charging and docking stations, and power supplies for the portable medical market. The primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.

  • Quality representative for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives
  • Develop, maintain and improve Electrochem’s supplier management program while assuring alignment and supporting Greatbatch Inc. Supply Chain Organization initiatives and policies
  • Determine strategies for continuous improvement in supplier quality and supply chain metrics
  • Manage supplier’s corrective actions system (investigation, documentation and implementation of corrective action and the verification of their effectiveness)
  • Design and/or specify inspection methods, tools, and test equipment to ensure product quality and design integrity are appropriately maintained. Also implements appropriate inspection sampling plans using statistical methods
  • Coordinate the disposition of non-conforming raw material
  • Manages the suppliers’ product and process change notification (PCN) system, including coordinating biocompatibility assessments
  • Review and approve changes to supplier related documents (procedures, drawing, etc.)
  • Perform component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing and/or performing the change
  • Participates in supplier’s design review, product validation, design verification, Risk Management plans/reports (dFMEA, pFMEA)
  • Performs risk analysis for existing and new raw materials / components
  • Develop and conduct statistically designed experiments to determine sources of material / component variability so that product quality is maintained or improved
  • Monitor and assure Electrochem’s supply chain activity and procedure set is compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation.
  • Support Greatbatch, Inc. Supplier Management activities

Greatbatch - 2 years ago - save job
About this company
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ElectroChem Incorporated was founded in 1986 with a strong reputation for successful problem solving in the field of fuel cells - a...