Our client, a global leader in the medical device industry, is seeking a highly skilled and experienced Senior Software Quality/Validation Engineer to join their team.
This senior role focuses on ensuring the quality and compliance of computerized systems while contributing to innovation in a regulated, high-impact industry.
Responsibilities: Lead the validation and operational management of computerized systems to ensure compliance with industry standards and regulatory requirements.Develop, review, and approve comprehensive validation documentation, including validation protocols, reports, and risk assessments, in line with 21 CFR Part 11, Data Integrity, and company policies.Conduct detailed Software Compliance Assessments, ensuring adherence to regulatory frameworks and quality standards.Oversee developing and maintaining quality-related procedures, work instructions, and system documentation to uphold compliance and operational excellence.Drive continuous improvement by identifying trends, reporting metrics, and implementing initiatives to enhance system validation processes.Act as a liaison between cross-functional teams to ensure alignment on validation strategies, quality goals, and compliance initiatives.Present validation status updates, key performance metrics, and improvement plans to senior leadership.Mentor junior team members and provide expert guidance on software validation practices, regulatory requirements, and quality management systems.Qualifications and Experience: A relevant third-level qualification in Engineering, Manufacturing, or Science; a master's degree is a plus.Minimum of 5 years of experience in software validation within the medical device industry or a similarly regulated environment (e.g., pharmaceutical or biotechnology).Strong knowledge of regulatory frameworks, including 21 CFR Part 11, 21 CFR 820, ISO 13485, and Data Integrity standards.Proven experience with validation methodologies (e.g., IQ/OQ/PQ), risk management, and traceability practices.Demonstrated ability to manage multiple projects and priorities in a fast-paced, regulated environment.Exceptional analytical, communication, and organizational skills with a detail-oriented mindset.Leadership experience in guiding teams, managing stakeholders, and driving compliance initiatives is desirable.Benefits: Comprehensive family health insuranceExcellent pension schemeLife assuranceCareer development opportunities in a global organizationAccess to a state-of-the-art facility and innovative projectsA growing business with numerous pathways for professional growthAdditional benefits tailored to support employee well-being and successFor a confidential discussion and more information on the role, please contact Kevin Griffin. ****** (021) 2427108
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