Quality Engineer II, Medical Devices (ISO 13485)

Luminate Medical; Galway; On-site; EUR 55,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Headphones

Camera

Flexible working hours

Generous vacation policy

Job summary

Luminate Medical is seeking a Quality Engineer II to support and scale our quality function as we move from development to commercial stage. You will provide specialist quality and technical support across departments, maintain the QMS, and help ensure compliance with ISO 13485 and FDA regulations.

The role emphasizes process optimisation, training, and collaborative problem-solving in a fast-paced startup environment with flexible benefits and a strong focus on patient impact.

Qualifications

• Level 8 degree or equivalent in Engineering/Science/STEM (incl. ASQ CQE).
• Minimum of 2 years relevant engineering experience in an ISO medical device company.
• Strong understanding of ISO 13485 and FDA Part 21 CFR 820.
• Excellent problem-solving and root cause investigation skills.
• Proficient in using QMS and MS Office Suite.
• Good documentation skills and attention to detail.
• Strong communication and organisational skills.
• Proactive approach to problem-solving.
• Ability to work independently with minimal supervision and cross-functionally.
• Confident communicating with internal and external stakeholders.

Responsibilities

• Support design and manufacturing activities through new technology/techniques and process improvements.
• Provide specialist quality and technical engineering support to all departments.
• Maintain and improve the Quality Management System per ISO 13485 and other regulations.
• Monitor companywide training and compliance.
• Coach and train employees within the job area.
• Set high standards and drive accountability in responsibilities.
• Participate in cross-functional teams and continuous improvement initiatives.
• Contribute to project milestones.
• Support regulatory activities for FDA submissions.
• Report progress against timelines to management.
• Identify opportunities to optimise processes.
• Participate in audits as required.
• Engage in job-related training courses.

Skills

Detail-oriented

Ethical and professional

Accountable

Proactive problem-solving

Collaborative

Clear communicator

Quality mindset

Education

Level 8 degree/Engineering or Science

ASQ CQE (advantage)

Tools

MS Office Suite

Quality Management System (QMS)

Job description

Luminate Medical is seeking a Quality Engineer II to support and scale our quality function as we move from development to commercial stage. You will provide specialist quality and technical support across departments, maintain the QMS, and help ensure compliance with ISO 13485 and FDA regulations.

The role emphasizes process optimisation, training, and collaborative problem-solving in a fast-paced startup environment with flexible benefits and a strong focus on patient impact.