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Quality Engineer

$62,400    Stoughton, MA
•  Direct Hire
•  Job Number:202254
•  Posted:12/2/2019

Micro Tech is seeking an experienced Quality Engineer to join the team of a local medical device manufacture in South Shore, MA! This is a direct hire opportunity, working full-time, Monday through Friday; 8:30AM-5:00PM and paying $62,400.00/YR (Depending on candidates level of experience).

  • Investigate Quality issues arising from supplier operations and manufacturing sites to identify root causes and recommend appropriate actions
  • Analyze field returns, production data and other information to understand and correct design, manufacturing and user-related problems
  • Takes a leadership role in assuring all activities in the area of equipment and process validations meet FDA and International regulatory requirements
  • Other production duties as necessary

Requirements

Requirements:

  • 10 years of experience in medical device industry with experience in high volume medical device manufacturing
  • Excellent communications skills
  • Demonstrated ability to work in a fast-paced environment and team building
  • FDA/QSR expertise desired
  • Proficient in the use of the Microsoft Office suite required
  • Experience in developing and maintaining typical manufacturing metrics
  • Demonstrated competence in performing effective troubleshooting
  • Excellent problem solving skills (root cause analysis).
  • Proficient with MS Office
  • ASQ certification with active local membership is preferred.
  • Ability to work on problems with limited direction.
  • Demonstrated knowledge of Quality Management System requirements in FDA regulated environments and understanding of ISO 13485 and applicable Medical Device Directives
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