Senior Software Quality Engineer

Job Overview

Our client is Limerick is looking for a Senior Software Quality Engineer to join their R&D team. The successful candidate will be accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams.

This role offers the opportunity to work with cutting-edge technology in an innovative and collaborative environment. This company offers a great benefits package and a competitive salary.

Main duties of Senior Software Quality Engineer:

  • 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

Role Requirements

The successful candidate must have 5+ years' experience working in a Software Quality Design or Software Testing role in a Medical Device Environment.

You must have knowledge/experience in the following:

  • Defect Tracking
  • Agile Scrum
  • Verification and Validation Planning/Testing
  • Software Integration Testing
  • Risk Management
  • Experience in Manual/Automation Testing
  • Working with standards
  • Good attention to detail in reviewing plans/protocols/reports
  • Working in Medical Device environment (FDA regulated, ISO13486)
  • Experience or strong understanding in IEC62304 - Medical Device Software
  • Design Control experience for 21CFR Part 820 or ISO 13485
  • Good Documentation Practice

Qualifications:

  • A minimum of 5 years of experience working within a quality function.
  • A minimum of 5 years of experience working in a FDA or ISO regulated environment.
  • A minimum of a bachelor's degree is required.

Key Contact

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