Engineer, Quality in Minneapolis, MN at Volt

Date Posted: 6/26/2019

Job Snapshot

Job Description

Quality Engineer (6-month contract) $40-45/hr.
Plymouth, MN

Objective: 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.

Qualifications:

  • Bachelor level degree in Engineering, Technical Field, or equivalent.
  • 3+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills.
  • Demonstrated¬†project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

Volt is an Equal Opportunity Employer