Senior Software Quality Engineer with 5+ years experience required for permanent role with an innovative multinational in Co. Limerick.

 

Responsibilities:

  • Quality Systems Development- Develop a Quality system to support design activities, provide guidance and quality oversight to ensure projects are aligned with regulatory and industry requirements. i.e. IEC 62304.
  • Help facilitate document reviews and assist with test case reviews.
  • Create receiving and material handling SOP’s and OOS SOP/Investigation Management.
  • Help project teams understand process and requirements, help facilitate technology integration, provide guidance to team and application of design controls 21CFR 820.30 for new product development.
  • Create and support documentation.

Requirements:

  • Bachelor’s Degree ideally in a software discipline
  • 5+ years’ experience working in a Software Quality Design or Software Testing role in a Medical Device Environment
  • Experience with Defect Tracking, Agile Scrum, Verification and Validation Planning/Testing, Software Integration Testing, Risk Management, Manual/Automation Testing
  • Experience working in Medical Device environment (FDA regulated, ISO13485)
  • Experience or strong understanding in IEC62304 – Medical Device Software

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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