Software Quality Assurance Engineer

We are delighted to be representing a highly innovative Med-Tech company in Dublin, on a permanent Software QA Engineer as they move through a significant moment of growth.

The Software QA Engineer will support quality and compliance activities associated with the software and drive the execution of related objectives.

As Software QA Engineer your responsibilities will include:

• Participate in cross functional product development and provide practical QA and Design Assurance expertise, in particular related to software design and development, verification and validation, risk management, manufacture and control
• Drive software quality assurance process optimisation and improvements, as needed, to ensure that all software quality systems remain fit for purpose and satisfy all customer requirements
• Collaborate with the wider team to ensure that necessary and sufficient QA activities are planned, executed, and recorded
• Ensure computer system validation (CSV) processes are in place and followed
• Manage suppliers to support quality assurance of product software and assessment/validation of QMS software
• Engage with the QMS and the organisation to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives

Experience & Education Required:

• Bachelor’s Degree in Engineering, Science or software related field
• 3+ years’ experience in medical device quality/design assurance role with focus on medical device software (or similar regulated industry such as pharmaceuticals)
• Strong knowledge of the software development lifecycle (i.e. IEC62304)
• Recent regulatory experience including FDA regulations, Medical Device

This is a fantastic role with an innovative company and product!