Senior Software Quality Engineer
📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related technical field
Role Overview
A leading global medical technology organization is seeking a Senior Software Quality Engineer to support research and development programs focused on innovative medical technologies.
This role will be responsible for establishing and maintaining software quality processes, regulatory compliance, and design control systems to ensure the successful development and delivery of high-quality medical device software.
The position plays a key role in new product development, manufacturing transfer, and quality management system implementation, ensuring software systems meet both regulatory standards and customer expectations.
Key Responsibilities
Software Quality & Compliance
Develop and maintain software quality strategies, processes, and procedures
Ensure compliance with medical device regulatory standards including:
FDA 21 CFR Part 820
FDA 21 CFR Part 11
ISO 13485
ISO 14971
IEC 62304
EU MDR 2017/745
Guide computer system validation (CSV) and electronic records compliance
Design & Development Quality
Support software lifecycle activities including:
Requirements management
Software development planning
Risk management
Verification & validation (V&V)
Facilitate design reviews and functional reviews
Review and approve technical documentation including:
Design documentation
Verification and validation protocols
Product drawings
Cross-Functional Collaboration
Represent the Quality function within New Product Development teams
Work closely with R&D, manufacturing, and engineering teams
Support technology transfer initiatives between development and manufacturing environments
Continuous Improvement & Quality Systems
Contribute to the development and implementation of quality management systems
Support CAPA investigations and remediation activities
Drive improvements in test coverage, software reliability, and system performance
Data Analysis & Problem Solving
Apply statistical tools and quality methodologies to:
Identify root causes
Analyse product or process issues
Implement corrective actions
Required Qualifications
Bachelor’s degree in:
Software Engineering
Electrical Engineering
Biomedical Engineering
Mechanical Engineering
Or a related technical discipline
6–7 years of professional experience in engineering or quality roles
At least 4+ years of experience in software development lifecycle or software quality
Strong understanding of medical device regulatory requirements
Experience with:
Software validation
Design controls
Risk management processes
Strong analytical, problem-solving, and communication skills
Preferred Experience
Experience in medical devices, healthcare technology, or regulated environments
Familiarity with CAPA processes and audit remediation
Knowledge of:
Six Sigma methodologies
Root cause analysis tools
Statistical sampling techniques
Experience working on cross-functional product development teams
Ideal Candidate
The ideal candidate is a software quality specialist within regulated industries who:
Has strong experience in medical device software compliance
Understands design controls and validation processes
Can support new product development programs
Works effectively with cross-functional engineering teams
Applies structured problem-solving and quality methodologies
Why Join
Opportunity to work on cutting-edge medical technologies
Collaborative engineering and research environment
Work with global teams driving healthcare innovation
Strong culture of professional growth and technical excellence