Engineer, Quality in Westford, MA at Volt

Date Posted: 10/8/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Westford, MA
  • Duration:
    24 weeks
  • Date Posted:
    10/8/2019
  • Job ID:
    200830
  • Pay Rate
    $0.0 - $46.04/Hour
  • Contact Name
    Volt Branch

Job Description

FDA Quality Engineer/Quality Engineer – 6 months – Westford MA

Volt Workforce Solutions is seeking a Quality Engineer for a 6-month contract with a leading medical device client located in Westford, MA. 

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.

Requirements:

•             Bachelor of Science or higher degree in Mechanical or Industrial Engineering, or equivalent

•             2+ years of industry experience in ISO-9001 environment, preferably medical device.

Please contact Debbie Linville at (317) 599-4893 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer