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