Engineer, Quality in Plano, TX at Volt

Date Posted: 7/11/2019

Job Snapshot

  • Employee Type:
  • Location:
    Plano, TX
  • Duration:
    16 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
    $0.0 - $45.4/Hour
  • Contact Name
    Volt Branch
  • Phone

Job Description

Are you a Quality Engineer with experience initiating medical device quality assurance activities?

Do you have knowledge of FDA Quality System Regulation, ISO13485 and other international standards?

Have you supported device complaint investigation and failure analysis?

Then this is the position you have been dreaming about!!!

Position:      Quality Engineer

Location:     Richardson, TX

Duration:     6-12 month contract

Rate:            $40/hr - $45/hr

Our client is seeking a Quality Engineer in the Richardson, TX area for a 6+month contract. 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, sub assemblies 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.