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Software Quality Engineer

I am partnering with a global Medical Technology organisation to secure a Software Quality Engineer to support their Software-based Medical Device division in North Carolina on a 6 month contract initially.

The Software Quality Engineer will be responsible for providing Quality oversight for product development activities, maintaining the non-product validation program, and coordinating product recall activities.

Key Responsibilities:

  • Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development
  • Serves as the Quality & Regulatory stakeholder for product development release team and a key member of the product risk assessment teams
  • Prepares all QARA product development deliverables
  • Reviews and approves product design documentation and product documentation to ensure readiness for FDA submissions
  • Support root cause analysis activities for the investigation of product complaints
  • Assists in the planning and execution of verification and validation testing
  • Performs New Product Development gate audits to ensure project deliverables adhere to governing processes
  • Responsible for managing all tool and process validations - reviews and approves all validation documentation
  • Maintains Master Validation List (MVL) and facilitates annual review of MVL
  • Assists with CAPA investigations and ensures corrections and/or corrective actions
  • Identifies and implements process improvement initiatives

Experience and Skills required:

  • 3+ years' experience in quality engineering role in the Medical Device industry
  • Engineering Degree (ie. Electrical, Biomedical) or other technical degree
  • Medical Device New Product Development experience
  • Experience with software-based products in a regulated industry (ideally IEC 62304 etc)
  • Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs etc.)
  • Experience with requirements management tools and systems engineering concepts desired
  • CQA, CQE or RAC desired

If this is of interest, please apply now!

Interviews are happening 6/27 & 6/28!

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