Engineer, Quality in Maplewood, MN at Volt

Date Posted: 3/11/2020

Job Snapshot

Job Description

Quality Engineer

$45.00-Saint Paul

12+ mths. strong possibility of direct

Volt is seeking a Quality Engineer for a well know medical device manufacturer for their Saint Paul location.

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.

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. 

Volt is an Equal Opportunity Employer