Quality Engineer I in Minneapolis, MN at Volt

Date Posted: 2/11/2020

Job Snapshot

Job Description

Quality Engineer (8-month contract) $45/hr. (DOE)
Plymouth, MN

Volt has partnered with a growing manufacturing client in search of a Quality Engineer! In the role, you will consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities for LifeScan. Occasionally write and execute test protocols and reports.

Responsibilities:

  • Execute and support on-time completion of Design Control Deliverables
  • Create the FAI (First Article Inspection), SIR (Special Inspection Requests) and RIP (Receiving Inspection Process) documents
  • Complete Document Change Request Reviews in a timely and objective manner
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support receiving inspection method development
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications Additional duties may be identified by functional management based on the current project/business objectives.

Requirements:

  • Bachelor’s Degree in engineering
  • 0-3 years of experience
  • Medical device background preferred

Volt is an Equal Opportunity Employer