Quality Engineer I – Medical Devices

Location: Galway (On-site)
Industry: Medical Device / Start-up
Our client, a dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team. The company is focused on developing innovative, patient-centric technologies to improve quality of life and is advancing rapidly through the product development lifecycle toward global market launch.

This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing Quality Management System. The ideal candidate will enjoy working in a cross-functional, start-up environment and contributing directly to impactful product development.

Responsibilities include but are not limited to the following:

• Apply quality engineering expertise across the Quality Management System (QMS).

• Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.

• Assist with design assurance activities, including design controls, verification, and validation.

• Support development and validation of test methods and computer system assurance programs.

• Participate in risk management and usability engineering activities.

• Maintain document control through QT9 eQMS and perform related administrative tasks.

• Contribute to the CAPA and non-conformance (NC) investigation and resolution process.

• Assist in internal and external audits and implement corrective actions as needed.

• Support updates and gap assessments for applicable regulatory standards and guidance.

• Participate in supplier quality management, vendor evaluation, and AVL maintenance.

• Collaborate cross-functionally to uphold quality objectives and continuous improvement.

• Perform additional quality-related duties to support business goals and KPIs.