Job Description

As a Software Validation Engineer, you will join a Global Medical Device organisation as their Software Validation site lead, sitting in and supported by a strong and tenured Quality function.

Your day to day;

• Lead Software Validation Activities: Own and drive the validation of quality and manufacturing software systems to ensure compliance with FDA, ISO 13485, and other regulatory requirements.
• Quality Systems Software Validation Lead: Act as the site lead for all software validation activities, overseeing validation plans, protocols, execution, and documentation.
• Support Software Implementation & Improvements: Collaborate with IT, Engineering, and Quality teams to ensure new software applications and updates meet validation and regulatory standards.
• Develop and Maintain Validation Documentation: Establish and maintain software validation documentation, including risk assessments, validation plans, test scripts, and traceability matrices.
• Ensure Compliance in Software Lifecycle Management: Support software lifecycle activities, including change control, periodic reviews, and retirement of validated systems.
• Provide Technical Leadership: Guide cross-functional teams in applying software validation best practices, ensuring efficient and compliant system implementations.
• Regulatory & Quality Support: Assist in regulatory inspections and ensure software validation processes meet audit expectations.

Your Skills and Expertise

To set you up for success in this role, the following qualifications are required:

• Bachelor’s Degree or higher in Engineering, Computer Science, or a related field (minimum level 8).
• Five (5) years of experience working in a regulated environment, specifically in medical devices, FDA, or ISO 13485-registered industries.
• Strong understanding of software validation principles and regulatory requirements for software used in medical device manufacturing and quality systems.

Additional Qualifications That Will Help You Succeed

• Experience with JIRA, Qtest, VERA for documenting the software lifecycle.
• Knowledge of Oracle, FactoryTalk, PEMAC, Bartender is advantageous.
• Familiarity with risk management, test automation, and software change control processes.

For more on this contact Johanne at 086 4403725 or choices@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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