Connecting...

Software Quality Consultant

Background:

I have an opening with a big medical device/biotech company in Sorrento Valley. My client is looking for a Software Quality Consultant who has experience in software, but is more well versed in aspects of med device quality (ISO standards, risk management, design history files, etc...)

Responsibilities:

  • Writing standard operating procedures.
  • Working with Software Development Life Cycle (SDLC).
  • Risk management.
  • Background as a software engineer/heavy familiarity with technical aspects of software development.
  • ISO standards including 13485, and IEC 62304.
  • Work with software product quality within a heavily regulated industry.
  • This position will not be a testing position. Experience in testing is ok, but this role will be more quality focused than testing focused.


Requirements:

  • Experience working in heavily regulated industry with a software product
  • Medical device experience preferred
  • Software background
  • ISO 13485, and IEC 62304.

Sthree US is acting as an Employment Business in relation to this vacancy.