Sr. Quality Engineer - New Product Introduction
Electrochem - Beaverton, OR

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Electrochem, a subsidiary of Greatbatch, Ltd, is seeking a Sr. Quality Engineer – New Product Introduction. Electrochem specializes in customized rechargeable and non-rechargeable battery cells, battery packs, charging and docking stations, and power supplies for the portable medical market.

  • Manage customer Quality issues for assigned customers to resolve issues and improve customer partnerships
  • Represent Quality on NPI teams for assigned customers by developing quality and inspection plans, sourcing strategies and first article inspections.
  • For assigned commodities manage supplier corrective action and supplier improvement
  • Monitor special processes with statistical process control methodology
  • Support improvements to Beaverton ISO 9001, ISO 13485 and FDA QSR programs including database development
  • Support company wide quality initiatives as applicable
  • Support additional projects, Lean activities and Quality improvement as assigned
  • Lead problem solving teams using DMAIC or PDCA
  • Support the RMA process with timely failure analysis

  • Bachelor’s degree with at least 3 years experience in an ISO 13485 manufacturing environment – OR - ASQ Certified Quality Engineer and at least 4 years experience in an ISO 13485 manufacturing environment – OR - 10 years experience in Quality, with at least 5 years in an ISO 13485 manufacturing environment
  • Experience with high tech. mechanical and electrical products
  • Strong team, communication and problem solving skills
  • General knowledge of MRP systems including BOMs, revision control and ECOs
  • General software application skills: Excel, Word, Outlook and Access
  • Experience establishing SPC programs and interpreting control charts
  • Capable of conducting valid measurement systems analysis and Gage R&R studies for both variable and attribute data types

  • Knowledge of, and ability to work with, portable power supply systems.
  • Experience using MiniTab statistical software
  • Experience using DataMyte SPC Software
  • Experience applying IPC standards to quality inspection
  • Experience designing and conducting Design of Experiments (DOE)
  • Experience supporting a Lean Manufacturing environment
  • Outsourcing experience, particularly Asia
  • Experience in administering the Production Part Approval Process as a supplier quality assurance tool and conducting PPAP responses for Micro Power customers
  • Able to prioritize and multitask
  • Enjoy working with a wide range of people, cultures and products

  • Travel, including International, to suppliers and customers as needed
  • Must be able to lift at least 20 lbs
  • Must be able to sit for long periods of time at a computer

Greatbatch - 20 months ago - save job - block
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About this company
5 reviews
ElectroChem Incorporated was founded in 1986 with a strong reputation for successful problem solving in the field of fuel cells - a...