ISO 13485

Senior Software Quality Engineer – Medical Devices | Limerick, IRE

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

 

Senior Quality Engineer – Design Assurance | Medical Devices | Limerick, Ireland

Senior Quality Engineer – Design Assurance

📍 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 discipline preferred

Role Overview

A global medical technology organization is seeking a Senior Quality Engineer – Design Assurance to support new product development and sustaining engineering projects.

In this role, you will act as the Quality representative on cross-functional project teams, ensuring that products meet global regulatory requirements and internal quality standards throughout the entire product lifecycle—from concept and development through product launch and ongoing support.

You will play a critical role in design controls, risk management, verification & validation, and regulatory compliance, helping deliver high-quality medical technologies that improve patient care.

Key Responsibilities

Design Assurance & Product Development

  • Represent the Quality function on project core teams for new product development and design change projects

  • Support product lifecycle activities from concept through launch and maintenance

  • Ensure compliance with design control, risk management, and change control processes

Risk Management & Compliance

  • Lead risk management activities throughout the product development lifecycle

  • Support compliance with key standards such as:

    • ISO 13485

    • ISO 14971

    • IEC 60601

    • IEC 62304

    • EU MDR

  • Ensure regulatory requirements are integrated into development activities

Verification & Validation

  • Support development and execution of verification and validation (V&V) strategies

  • Review and approve test plans, protocols, and reports

  • Evaluate statistical approaches and challenge testing methodologies where necessary

  • Authorise and assess deviations during testing activities

Documentation & Quality Systems

  • Contribute to the creation and maintenance of Design History File (DHF) documentation

  • Support Quality Management System (QMS) activities including:

    • CAPA investigations

    • Field assessments

    • Operational engineering evaluations

  • Ensure accurate documentation and traceability across development programs

Issue Management & Continuous Improvement

  • Support failure investigations and root cause analysis

  • Manage software issue tracking in accordance with IEC 62304

  • Promote a strong quality culture across project teams

Required Qualifications

  • Bachelor’s degree in Engineering or related technical discipline
    (Equivalent experience considered)

  • Minimum 5+ years of experience in Quality Engineering within a regulated environment

  • Strong knowledge of:

    • ISO 13485

    • QSR / FDA quality requirements

    • ISO 14971 risk management

    • Statistical analysis techniques

  • Experience with:

    • Design assurance processes

    • Design controls and change control

    • Risk management methodologies

  • Strong written and verbal communication skills

  • Ability to manage multiple projects and priorities simultaneously

Preferred Experience

  • Experience with EU Medical Device Regulation (MDR)

  • Knowledge of:

    • IEC 62304 (medical device software lifecycle)

    • IEC 62366 (usability engineering)

  • Experience supporting software-enabled medical devices

  • Experience working with cross-functional product development teams

Ideal Candidate

The ideal candidate is a Quality Engineer experienced in regulated product development who:

  • Has strong expertise in design assurance and risk management

  • Understands the medical device regulatory landscape

  • Can effectively influence cross-functional engineering teams

  • Demonstrates strong attention to detail and analytical thinking

  • Promotes a patient-first approach to quality and compliance

 

Your new job awaits.

Start the process →