Software Assurance Professional
4 days ago
Mason Alexander is a highly innovative Med-Tech company based in Dublin, undergoing significant growth. We are seeking a skilled Software Quality Assurance Engineer to support our quality and compliance activities associated with software development.
About the Role
The Software QA Engineer will be responsible for driving software quality assurance process optimisation and improvements, ensuring that all software quality systems remain fit for purpose and satisfy customer requirements.
Key responsibilities include:
- Participate in cross-functional product development, providing practical QA and Design Assurance expertise, particularly related to software design and development, verification and validation, risk management, manufacture, and control.
- Collaborate with the wider team to ensure necessary and sufficient QA activities are planned, executed, and recorded.
- Manage suppliers to support quality assurance of product software and assessment/validation of QMS software.
- Engage with the QMS and organisation to ensure delivery of the overall quality strategy and support the achievement of business quality objectives.
This role requires strong knowledge of the software development lifecycle (IEC62304) and recent regulatory experience including FDA regulations and Medical Device Regulations.
A Bachelor's Degree in Engineering, Science, or a software-related field, along with 3+ years' experience in medical device quality/design assurance roles, focusing on medical device software, is required.
This is a mid-senior level position, working full-time in a dynamic environment.
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