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Manufacturing Quality Engineer

Company: Resolvit, LLC.
Location: Worcester
Posted on: November 20, 2020

Job Description:

The Quality Engineer is responsible for leading and mentoring team members in Using measurement equipment to measure the dimensions of the product Visual inspections Incoming Inspections Understanding and use of ERP system (iQMS) Understanding and use of ISO 13485 procedures as they relate to Quality function Compiling, analyzing, and interpreting inspection data Leading other projects and duties Other Responsibilities 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 Use and programming of OGP SmartScope Ability to run Coordinate Measuring Machine (CMM) for inspections PC DMIS CMM programming a plus. Qualifications Experience leading teams Experience within the medical device industry Experience working within an ISO 13485 quality system Experience with 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.) Gage RR Knowledge of reading and interpreting specification drawings Working experience and knowledge of GDT. 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 Detail oriented Able to make good decisions based on facts ELF Vision System experience a plus FDA Regulatory experience a plus

Keywords: Resolvit, LLC., Worcester , Manufacturing Quality Engineer, Other , Worcester, Massachusetts

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