Engineer, Quality in Minneapolis, MN at Volt

Date Posted: 9/2/2018

Job Snapshot

Job Description

Quality Engineer (6-month contract) Plymouth, MN ***3 openings!

$40-45/hr. DOE
 

Volt has partnered with a growing manufacturing client in search of a Quality Engineer! 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.

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. Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.

Qualifications:

  • BS degree in Engineering or equivalent.
  • 3-5 years quality experience in a manufacturing environment with demonstrated ability to produce results.
  • Moderate knowledge of theories, practices and procedures in a quality function.
  • Works on problems of moderate scope where root cause and data analysis is required.
  • Interacts with internal personnel in a cross-functional environment. 
  • Follows established practices and procedures in the performance of normal job functions.
  • Good oral and written communication skills.

Volt is an Equal Opportunity Employer