Senior Software Quality Assurance Engineer

Location: Fully on site in Limerick, Ireland

Contract: Full-Time (40 hours weekly), Permanent Role

Company:

As one of the world’s leading global medical technology organizations, our purpose is to advance the future of health—and that mission is anything but small. It requires imagination, passion, and collaboration across every discipline, from design and engineering to manufacturing and marketing. Together, we transform challenges into breakthroughs and turn ambitious ideas into real‑world possibilities.

A career here means learning from and working alongside inspiring leaders and colleagues who are deeply committed to fostering an inclusive, growth‑focused, and rewarding culture. You’ll have the opportunity to shape the direction of the organization while building a meaningful legacy of your own.

We seek individuals who can see the broader vision—those who understand the human story behind every innovation. If you bring curiosity, creativity, and a drive to reinvent the future of health, you’ll find a place where you can learn, grow, thrive, and take pride in making a positive impact on the world.

The Senior Software Quality Engineer serves as an emerging Subject Matter Expert within cross‑functional project teams, particularly in areas such as new product development, manufacturing transfer, and specialized initiatives. This role ensures that all software‑related deliverables meet customer expectations and comply with key regulatory standards, including 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304, IVDD 98/79/EEC, and EU MDR 2017/745.

The engineer leads computer system validation activities, evaluates compliance with electronic records requirements, and oversees essential quality processes such as design planning, risk management, design reviews, and change control for both application and embedded software.

In addition, the Senior Software Quality Engineer reviews and approves critical documentation—including product drawings and verification/validation protocols—while applying statistical tools to analyze data, identify root causes, and drive effective corrective actions. Their expertise ensures that software products are developed and released with strong quality assurance, supporting continuous improvement across software and quality functions.

• Develop, refine, and maintain strategies and plans to elevate overall software quality, including test coverage and system performance.
• Provide both strategic and tactical support to the Quality Engineering function, grounded in an understanding of 21 CFR Part 820 and ISO requirements.
• Lead and facilitate Design Reviews and Functional Reviews for software products.
• Collaborate with Manufacturing and R&D to support software products, drive design improvements, and monitor measurable enhancements.
• Ensure divisional and departmental policies, procedures, and facilities comply with all applicable regulatory guidelines.
• Represent the Quality function on New Product Development and Technology Transfer core teams.
• Serve as a key contributor on software development projects, supporting activities such as requirements, development planning, risk management, verification/validation, and more.
• Address and remediate software‑related audit findings and CAPAs.

• 5+ years of experience working with Software in a Quality Assurance/ Control capacity
• Degree in Electrical, Mechanical, Software or Biomedical Engineering
• Must have experience within Life Sciences, Medical Devices
• Must have experience with Design & Functional Review (Reliability, Validation Planning, Statistical Sampling)
• Strong ability to manage multiple tasks and lead execution of change management plans.
• Skilled in quality engineering for design projects, reliability concepts for complex systems, validation planning, statistical sampling, Six Sigma root‑cause analysis tools, and project management techniques.
• Excellent written communication skills with a focus on clarity and accuracy.
• Strong verbal communication skills across one‑on‑one discussions, group settings, and formal presentations.
• Effective listener who considers input from colleagues, managers, peers, and customers when solving problems.
• Proficient in systematic analysis tools, including root‑cause analysis, failure analysis, and risk assessment.
• Demonstrated ability to drive results and navigate conflict within team environments. xcfaprz
• Working knowledge of FDA 21 CFR 820 and relevant ISO standards.