Quality Engineer (Metro West Boston)

 

Our client is an established provider of manufacturing services to the medical device industry with a long track record of stability and growth.  

 

Overview

 

A minimum of five years of medical device experience and a 4 year degree is required.  ASQ CQE or SSBB certification preferred. Quality systems (QSR 21 CFR Part 820) and ISO13485 expertise required.  Technical degree in an engineering or related discipline such as computer science or statistics is preferred. Well versed in statistical techniques and data analysis and expertise using one or more statistical software packages (Minitab, Stat-Pro, Statistica, etc.) is required. Excellent written and verbal communication skills required.  This opportunity requires a high energy candidate looking to help lead a customer focused continuous improvement mentality.

 

This position requires previous experience supporting product development teams and/or supporting continuous improvement efforts for products in production.  Well versed in acceptance sampling and process capability/process control.  Support validation requirements definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R and measurement systems analysis (MSA).

 

Previous experience and expertise in structured problem solving and root cause analysis. Participate in or lead corrective action initiatives. Define, remediate or optimize processes in compliance with QSR’s and organizational needs.

 

Please submit resume to: kprovost@biomedicalsearchconsultants.com

 

For more information, please visit www.biomedicalsearchconsultants.com