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Quality Engineer
Ref No.: 18-51400
Location: Raynham, Massachusetts
Position Type:Contract
Start Date: 07/20/2018
JOB SPECIFICATION: - (Please ignore if not a good match)

Role : - Quality Engineer (Medical Devices)

Location : - Raynham, MA
Interview : - Phone or Skype

Job Description:

Must have skills*
• Experience working in manufacturing/operations and a good technical understanding of inspection equipment and processes
• Experienced in developing measurement and inspection programs using Starrett HD Optical Comparators or Keyence Optical measurement systems is required
• Understanding of GMP/ISO regulations and validation regulations
• Previous project management and/or project leadership experience

Good to have skills*
• Good communication skill
• Manufacturing background with following skill
  • Worked in a machine shop environment
  • Good GD&T knowledge
  • Experience in Mechanical inspection
  • Experience in CMM operation
  • Experience in Validation documentation
  • Understanding of foundry mold qualifications
  • Understanding of basic Quality systems
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. including Measurement System Analysis, SPC, DOEs, Reliability, etc.)
• In-depth knowledge of product/process Risk Management (FDA and ISO standards)
• Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data
• Experience working in both an FDA and European regulatory

Key responsibilities*
• The Quality Engineer will utilize tools and methods for the development, transfer, and maintenance of test methods.
• 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.

Key words to search in resume
CMM, GD&T, Mechanical inspection, developing measurement and inspection programs