Software Quality Assurance Engineer

Description:

BioTalent are currently working with a client based in Dublin with their search for a Software Quality Engineer for a fully remote, initial 6 month contract.

You will primarily be responsible for supporting teams through their quality system, to ensure that software is developed in compliance with internal procedures.

The Job

• Take full ownership of Design History Files for (DHF) for medical software development projects for Software as a Medical Devices (SaMD), legacy and new products.
• Develop and organize design documentation including user needs, software requirements specifications, design specifications, verification/ validation plans and protocols, and risk management.
• Lead and perform risk management activities for software products.
• Represent the Quality function in all software development core teams.
• Lead design reviews, change assessment and configuration management with Product teams.
• You will represent design quality in meetings with regulators (like FDA), Customers, investors and other important stakeholders.

Requirements

• 3+ years’ experience working in a similar role.
• Experience with the following standards: ISO13485, IEC62304, ISO14971.
• Understand Medical Software Quality, test methods and tools.
• BS/MS degree in Computer Science, Engineering or a related subject.