Senior Quality Engineer – Design Assurance

Location: Limerick
Employment Type: [Full-Time / Permanent]

About the Role

We are seeking a Senior Design Assurance Engineer to play a pivotal role in ensuring that both new product development and sustaining projects meet rigorous quality and compliance standards. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes, driving adherence to global regulatory requirements.

This role spans product inception through launch and maintenance and requires strong collaboration with cross-functional teams, excellent communication skills, and a proactive approach to quality assurance.

Key Responsibilities

• Serve as the Design Assurance Quality Engineer on project core teams for design change projects.
• Contribute to the formation and ongoing management of Design History File (DHF) documentation.
• Lead risk management activities across projects.
• Support compliance initiatives (e.g., IEC 60601) alongside relevant stakeholders.
• Ensure a patient-first approach to quality engineering.
• Support the creation, implementation, and review of verification and validation (V&V) activities.
• Collaborate closely with R&D to ensure comprehensive testing and execution of V&V plans.
• Review and approve testing procedures and documentation, including challenging statistical rationales.
• Assess and authorize execution deviations as appropriate.
• Conduct or assist in failure investigations and problem-solving sessions.
• Manage software issue tracking per IEC 62304, ensuring issues are logged, risk-assessed, and resolved.
• Ensure compliance across projects for design control, risk management, and change control processes.
• Advocate for a strong quality culture within project teams.
• Support other Quality Management System (QMS) activities such as CAPA, field assessments, and operational engineering evaluations.

Candidate Profile

• Relevant degree or equivalent experience (engineering degree preferred), or minimum of 5 years’ experience in quality engineering.
• Strong knowledge of ISO 13485, QSR, ISO 14971, and statistical techniques.
• Expertise in design assurance, including design controls, standards compliance, and risk management.
• Strong written and verbal communication skills.
• Strong organizational skills and ability to manage multiple priorities.
• Experience with Medical Device Regulations (MDR) is an advantage.
• Familiarity with IEC 62304 and IEC 62366 is advantageous.
• Ability to influence teams, identify potential blocking issues, and drive resolution.

Work Environment

• On-site collaboration is typically 4+ days per week, fostering innovation and effective problem-solving.
• Flexible arrangements may be available depending on the role.

Why Apply

This is a high-impact role offering exposure to complex quality engineering challenges across the full product lifecycle. Ideal candidates are proactive, detail-oriented, and motivated to ensure regulatory compliance and quality excellence.