Engineer, Quality in Plymouth, MN at Volt

Date Posted: 7/27/2020

Job Snapshot

Job Description

Quality Engineer (6-month contract)

Plymouth, MN


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.

Responsibilities:

  • 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.

Requirements:

  • Bachelor’s Degree in Science/Engineering (Mechanical, Electrical, Materials Science, Industrial, Chemical, Biomedical, Computer Sciences etc.)
  • 3-5 years’ technical experience in a medical device industry and/or in a broader enterprise/cross-division business unit model preferred.
  • Must have CAPA experience.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Ability to identify and solve problems and work independently with little oversight.

Volt is an Equal Opportunity Employer