Engineer, Quality in Minneapolis, MN at Volt

Date Posted: 1/15/2020

Job Snapshot

Job Description

Quality Engineer (9-month contract) $40-45/hr.
Plymouth, MN

Volt has partnered with a growing manufacturing company in search of a Quality Engineer! The purpose of this position is to initiate medical device quality assurance activities. The Quality Engineer to perform evaluations of returned products that have been deemed to potentially be manufacturing related. 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.

Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Deep understanding of manufacturing processes related to the device, various regulations and standards (ISO 13485, FDA Quality Systems, etc.), and engineering principals.
  • 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.
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

Qualifications:

  • Bachelor’s in engineering.
  • Seeks assistance for complex issues and exercises judgment within defined procedures and practices to determine appropriate action.
  • Demonstrates effective organization and prioritization.
  • Interacts well with diverse groups to maintain strong working relationships. Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
  • Negotiates and reconciles differences to work well with others in a collaborative, fast-paced, goal-driven environment.
  • Has the ability to train others effectively.

Volt is an Equal Opportunity Employer