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Quality Engineer Medical Device

The Fountain Group Westford, MA
  • Expired: over a month ago. Applications are no longer accepted.

Hello,

My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Engineer, Quality for a prominent client of ours. This position is located in Westford, MA Details for the position are as follows:

Job Description:

  • 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. 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.

If you are interested in hearing more about the position please respond to this posting with your resume attached.

The Fountain Group

The Fountain Group is a professional staffing firm specializing in providing contingent workforce solutions for a wide array of industries. The Fountain Group has been identifying and matching top talent with Fortune 100 – Fortune 500 companies throughout the United States and Canada since 2001, and has received numerous awards throughout the nation for our success within the MSP space. Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

Address

Westford, MA
01886 USA

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