Software QA Engineer

4 weeks ago


Dublin, Ireland Hero Recruitment Full time

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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