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 FIRE1 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 FIRE1 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 to 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