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

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 or Engineering@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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