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Sr. Quality Engineer in Andover, MA at SNI Technology

Date Posted: 3/12/2020

Job Snapshot

  • Employee Type:
  • Location:
    Andover, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Essential Functions:

  • Update all R&D/Quality documentation in line with the General Safety and performance requirements specified within the MDR legislation as well as new product groupings.
  • Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements.
  • Ensure that all product testing data is remediated and/or developed to MDR standards.
  • Update existing R&D/Quality processes for maintenance/creation of design history files as well as other supporting documentation.
  • Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation.
  • Prepare Design History files and other required supporting documentation for a notified body pilot.
  • Provides R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records.

Bachelor's degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field.

To apply to this position, please email with a copy of your most up to date resume.