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
ElectroChem Incorporated was founded in 1986 with a strong reputation for successful problem solving in the field of fuel cells - a...