Quality Assurance Engineer

2 weeks ago


Scarborough, United States Intellectt Inc Full time

Title: Quality Assurance Engineer (Medical Device)

Location: Scarborough, Maine

Duration: 06+ Month


Summary:

  • The purpose of this position is to initiate medical device quality assurance activities.
  • These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
  • This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.


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