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