Overview

Software Quality Engineer Jobs in Dublin, County Dublin, Ireland at Maclivaro Limited

Title: Software Quality Engineer

Company: Maclivaro Limited

Location: Dublin, County Dublin, Ireland

Software QA Engineer (Hybrid – Dublin)

Salary : €50,000-65,000

Are you passionate about driving software quality in a dynamic and innovative environment? Join a cutting-edge medical device company in Dublin as a Software QA Engineer and play a key role in ensuring the highest standards of quality, compliance, and reliability in medical device software.

Job Purpose

As a Software QA Engineer, you will be responsible for supporting quality and compliance activities related to software, ensuring that all processes align with regulatory standards. You will drive the execution of key objectives for the software lifecycle, from design through to validation and risk management.

Key Responsibilities

Collaborate with cross-functional product development teams, offering expert guidance in software design, development, verification, and validation.

Lead software quality assurance process optimization and improvements to ensure quality systems meet customer requirements and remain fit for purpose.

Ensure necessary QA activities are planned, executed, and thoroughly recorded.

Implement and maintain computer system validation (CSV) processes in compliance with applicable regulations.

Manage supplier relationships to support software quality assurance and QMS software validation.

Work with the Quality Management System (QMS) to ensure the overall quality strategy is delivered and business objectives are achieved.

Undertake additional ad-hoc duties as required to support the team.

Experience & Education

Essential:

Bachelor’s degree in Engineering, Science, or a software-related field.

3+ years of experience in a medical device quality/design assurance role, focusing on medical device software (or similar regulated industry such as pharmaceuticals).

In-depth knowledge of the software development lifecycle, especially IEC 62304.

Experience with regulatory frameworks, including FDA regulations, Medical Device Regulation (MDR), and other international standards.

Desirable:

Experience in cybersecurity for medical device software.

Familiarity with implantable medical devices.

Experience with medical electrical equipment.

Involvement in clinical investigations of medical devices.

Proficiency in Jira or other software development lifecycle tools.

Skills:

Proficient in technical design documentation and software development lifecycle processes/tools.

Strong communication and influencing skills, with the ability to listen and collaborate effectively.

Ability to work under pressure while meeting deadlines.

Capable of managing multiple projects and tasks simultaneously.

Self-motivated and target-driven, with the initiative to work independently.

Strong analytical and problem-solving abilities.

Comfortable working in a fast-paced, start-up environment.

If you’re ready to contribute to a fast-paced, high-impact environment while developing your career in a leading-edge industry, apply now!

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