Senior Design Quality Engineer – Medical Devices

Life Science Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is seeking a Design Assurance Quality Engineer to join a Galway-based medical device team. The role supports the New Product Development lifecycle, leading design controls, risk management and quality planning to ensure safety, regulatory compliance and successful product launches.

You will collaborate with cross-functional teams, suppliers and customers, maintain DHF/DMR documentation, drive CAPA and change control, and contribute to continuous improvement within ISO

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• Minimum of 3 years' experience in medical device design and development and/or Quality Assurance.
• Strong understanding of design controls, risk management and quality systems within the medical device industry.
• Familiarity with ISO 13485, FDA QSR and relevant medical device regulations.

Responsibilities

• Provide QA leadership across New Product Development projects, embedding quality throughout the product lifecycle.
• Lead and maintain DHF, DMR, design controls and risk management documentation.
• Ensure compliance with Quality Management System and medical device regulations.
• Lead design risk assessments evaluating functionality, safety and performance.
• Support CAPA, change control, document control, product release and supplier audits.
• Lead verification and validation activities with proper planning and documentation.
• Support pilot production, process development and scale-up activities.
• Collaborate with customers, suppliers and internal stakeholders to resolve quality issues.

Skills

Design controls

Risk management

Quality systems

eQMS

Statistics

Lean Six Sigma

CAPA

Education

Bachelor's degree in Engineering

Tools

eQMS

Job description

Life Science Recruitment is seeking a Design Assurance Quality Engineer to join a Galway-based medical device team. The role supports the New Product Development lifecycle, leading design controls, risk management and quality planning to ensure safety, regulatory compliance and successful product launches.

You will collaborate with cross-functional teams, suppliers and customers, maintain DHF/DMR documentation, drive CAPA and change control, and contribute to continuous improvement within ISO