Medical Device Quality Engineer (Systems/Test Method)

Boston, MA

Job ID: 131140 Industry: Medical Device

 

Medical Device Quality Engineer ( Systems/Test Method)

Environment:

Our client is a large medical device manufacturer that develops a number of Class II orthopedic products. They are currently in need of a Quality Engineer to come in and support the manufacturing floor.

Responsibilities:

Our client is seeking a Quality Engineer that will utilize tools and methods for the development, transfer, and maintenance of test methods. They will develop and assess the effectiveness of measurement systems, inspection set-up and staging for inspection and non-destructive tests for inspection processes. This person will participate in the risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes.  They will need to have experience in reading and interpreting mechanical drawings, CAD files, and DXF files. Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. Experience working in manufacturing/operations and a good technical understanding of inspection equipment and processes is required. 

Required:
 
  • Medical Device
  • Quality Engineering
  • Systems Engineering
  • Test Method Validation
  • Experienced in developing measurement and inspection programs using Starrett HD Optical Comparators or Keyence Optical measurement systems.

Job Type: Contract   

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