Senior Supplier Quality Engineer
The Resource Group Inc. - Portland, OR

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JOB SUMMARY:
We are seeking a Sr. Supplier Quality Engineer for our client who 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.

RESPONSIBILITES INCLUDE:
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 Quality Management initiatives

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