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Quality Engineer

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POST DATE 9/16/2016
END DATE 10/22/2016

Entegee Engineering Technical Group Minneapolis, MN

Minneapolis, MN
AJE Ref #
Job Classification
Full Time
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POSITION DESCRIPTION: Actively partnering with suppliers and establishing/agreeing upon expectations up front. Ensuring supplier processes are robust, and monitored/reported per required procedures. Regular reporting on key performance indicators for key suppliers based upon business and product risk. Ensuring system for managing sub tier suppliers in place for selected suppliers. POSITION RESPONSIBILITIES: ? Develop a strong relationship with supplier. ? Develop a robust risk management process for each supplier. ? Drive continuous improvements in the Supplier Quality organization by continuing to improve related systems and processes in Structural Heart. o Work to continue to harmonize and improve processes and practices with all businesses in Structural Heart. o Work with the supplier base to drive corrective/preventative action based on feedback from incoming inspection, manufacturing floor and contract manufacturers. o Lead improvements efforts as appropriate. o Drive supplier improvement/corrective actions based on supplier performance trends. ? Develop characterization and qualification strategies, protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation) ? Provide technical assistance to suppliers/other resources performing qualification/validation testing. Assure the resolution of all issues raised during testing ? Work with suppliers to resolve supplier related defects to assure that corrective actions are developed and implemented


EDUCATION REQUIRED: ? BS/BA degree in engineering or science YEARS OF
EXPERIENCE ? Minimum of 3-5 years related engineering experience ? Minimum
of 1-2 years in Medical Device Industry ? Minimum 2 years in Supplier Quality
SPECIALIZED KNOWLEDGE REQUIRED ? Use and understanding of Statistical
Tools (Design of Experiments, Measurement System Analysis, Process Capability
and Statistical Process Control) ? Ability read part prints and component
specifications ? Understanding of Geometric Dimensional Tolerancing (GDT)
? Ability to travel up to 20%. BASIC QUALIFICATIONS: ? 3-5 years related
engineering experience, with a minimum of 2 years? experience in Supplier
Quality ? Experience in the Medical Device Industry ? Oral and Written
communication skills ? Ability to work in a team/partnership environment
? Computer Skills (Microsoft- Word, Excel, Project, PowerPoint, Minitab)
DESIRED/PREFERRED QUALIFICATIONS (optional) ? Project Management experience
? Manufacturing experience in Injection molding materials, process development
tool design and visual standards ? 3-5 years? experience in Supplier Quality
? MS degree in science or engineering

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