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Quality Engineer

Company: Top Quality Recruitment (TQR)
Location: Springfield
Posted on: February 15, 2020

Job Description:

Position Summary: -- The Quality Engineer will be responsible for leading and mentoring team members. Using measurement equipment to measure the dimensions of the product. Understanding and use of ERP system (iQMS). Understanding and use of ISO procedures as they relate to Quality function. Leading other projects and duties. -- Key Activities: Performs root cause analysis and implements preventive and corrective actions. Performs test and validation activities. Developing and conducting process validation (IQ, OQ and PQ). Performing capability studies. Visual inspections. Incoming Inspections. Compiling, analyzing, and interpreting inspection data. -- Required Qualifications: Bachelor's Degree preferred. Experience leading teams. Experience within the medical device industry. Experience working within an ISO 13485 quality system. Experience with performing quality audits. Experience with Statistical Process Control (SPC), Design of Experiment (D.O.E.), High, Low, Nominal measurements. Experience with all aspects regarding capability studies. Experience developing quality and risk documentation (Process Flow Charts, FMEAs, Control Plans, Work Instructions, etc.) Knowledge of reading and interpreting specification drawings. Knowledge of GD&T is preferred. Experience working within an injection molding environment. Willing to do what it takes to get the job done right. Clearly communicates in English, both written and spoken. Able to make good decisions based on facts. Elf Vision System experience preferred. Preferred ability to run Coordinate Measuring Machine (CMM) for inspections. FDA Regulatory experience a plus.

Keywords: Top Quality Recruitment (TQR), Springfield , Quality Engineer, Engineering , Springfield, Massachusetts

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