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.

Quality of Life in County Westmeath, Ireland: 

County Westmeath offers a vibrant, welcoming community with a perfect blend of rural charm and modern amenities. Whether you’re an outdoor enthusiast or enjoy exploring historic towns, Westmeath provides a fantastic quality of life with access to beautiful natural landscapes, excellent schools, and thriving local culture. 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie 

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”