Direct message the job poster from HERO Recruitment
Principal Recruitment Consultant - Contact STEM@hero.ie or call 0868395533
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.
This role is ideal for a detail-oriented professional with a passion for software validation in a regulated environment. If you’re looking to make a meaningful impact in medical device quality and compliance, we’d love to hear from you!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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