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.

Organization BioTalent
Industry Engineering
Occupational Category Software Quality Assurance Engineer
Job Location Dublin,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Experienced Professional
Experience 3 Years
Posted at 2023-11-30 10:13 am
Expires on 2024-12-24