Medical Device Software Quality Engineer

This is a fully remote position, open to applicants in Ireland, +2 more countries.

📋 Description

• The Medical Device Software Quality Engineer will report directly to the Quality and Regulatory Affairs Manager.

• Responsible for ensuring software quality throughout the development of medical device products.

• Aid in the creation of IQ/OQ/PQ documentation, testing protocols, and validation reports for IVD software and regulated tools utilized in GxP environments in the US and Canada.

• Deliver QA oversight throughout the complete software and AI model lifecycle.

• Lead and uphold comprehensive risk management for software and AI.

• Assist in managing nonconforming products by documenting, tracking, and following up on nonconformances.

• Aid in the preparation and upkeep of Health Canada medical device license applications and MDSAP documentation.

⛳️ Requirements

• A degree or equivalent qualification in a relevant field (e.g., life sciences, engineering, quality management, regulatory affairs) or comparable experience.

• At least 3 years of experience in a quality, regulatory, or related position within a medical device, IVD, pharmaceutical, or regulated software setting.

• Solid understanding of ISO 13485 QMS requirements or FDA 21 CFR Part 820; familiarity with UK, EU, MDSAP, or Health Canada medical device regulations is a plus.

• Good knowledge of software as a medical device (SaMD) or IVD software concepts, including IEC 62304, is preferable.

• Experience with document control, CAPA, complaint handling, or audit support processes in a regulated setting is advantageous.

• Basic understanding of US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device license requirements; a willingness to acquire knowledge of MDSAP and relevant US/Canadian regulations is expected.

🏝️ Benefits

• Health insurance

• Professional development

• Flexible working arrangements