Senior Software Quality Engineer
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
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
- 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.