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Quality Engineer

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New Bedford, MA
$80,000 - $85,000
Job Type
Direct Hire
Apr 14, 2017
Job ID
We are recruiting for our New Bedford, MA client - they are looking to add a Quality Engineer for their medical and aerospace division.  This is a position that will take your career to the next level!  This company is about helping you create and achieve your career goals by providing you with support, development and leadership...a place to put down some roots and GROW.

As makers of medical and aerospace devices, the candidate's qualifications are critical.

  • 3-5 Years of experience in Quality Engineering
  • BS in any of the following engineering studies:  Mechanical, Electrical and Chemical
  • Strong understanding of ISO, 13485, FDA, QSR standards
  • Experience in quality relative to the medical or aerospace device industry
  • Supervisory experience
  • ASQ-CQE Certification desired
  • Knowledge of Solidworks or AutoCAD is preferred
  • US Citizen or Permanent Resident, (ITAR regulations in manufacturing plants)
  • Train and implement quality processes such as MRB, RMA, CAPA and NCMR
  • Perform analytical investigations and develop root cause for non-conformances and deviations as identified through scrap analysis, NCMRs and RMAs
  • Coordinate entire RMA process
  • Issue, monitor and evaluate CAPAs for effectiveness and timeliness
  • Create and/or process ECOs, process routers, drawings and other written documentation in accordance with quality system requirements
  • Monitor supplier performance through scorecard/grading, analyzing RI measurement data (SQC) and tracking NCMRs.  Perform supplier audits and visits as required
  • Maintain internal auditing program
  • Analyze data and generate reports from ERP data using Minitab and Excel
  • Responsible for internal audits per ISO 9001, ISO 14001, AS 9100 and ISO 13485
  • (IQ, OQ, PQ) Create validation protocols and assist in DOEs, ANOVA and other analytical methods to optimize processes
  • Implement and maintain SPC and SQC using Infinity QS
  • Develop quality plans, pFMEAs, and FMEAs for new and existing products
  • Create/update RI & Final Product MIR cards for product inspection and testing
  • Set up, program and operate CMM and SmartScope, as well as other measurement/inspection tools