Software QA Engineer
Location: Dublin (Hybrid – e.g., 3 days per week on site/2 days per week remote)
Job Purpose
The Software QA Engineer will support quality and compliance activities associated with software and drive the execution of related objectives.
Responsibilities
* 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.
* Other ad-hoc duties as required.
Experience & Education
Essential
* 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 Regulation (MDR) and other applicable national and international regulations and Standards
Desirable
* Experience with cybersecurity requirements for medical device software
* Experience in implantable medical devices
* Experience with medical electrical equipment
* Experience with clinical investigations of medical devices
* Experience with Jira or equivalent software development lifecycle tooling
Skills
* Demonstrated proficiency in technical design documentation and software development lifecycle processes/tools
* Strong communication and influencing skills – good listener
* Ability to work under pressure and meet deadlines
* Ability to manage multiple projects and deadlines
* Target-driven individual who can work on their own initiative
* Strong analytical and problem-solving abilities
* Ability to make decisions and own processes
* Thrives in a fast-paced start-up environment
Reporting
Reports to Software QA Manager
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