Our client is seeking a skilled Senior Software Quality Engineer to join their team. This role offers an exciting opportunity to contribute to a global medical device organization, ensuring the highest standards of quality and compliance in computerized systems. Responsibilities: Develop and review validation documentation in line with regulatory requirements and internal quality policies, ensuring a strong understanding of the Quality Assurance role. Conduct Software Compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet industry standards and regulatory requirements, including familiarity with 21 CFR 820 and ISO 13485 regulations. Maintain and continuously improve the quality and compliance status of associated procedures and work instructions, ensuring high attention to detail and accuracy in all deliverables. Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives, demonstrating effective time management and organizational skills. Support audits and regulatory inspections by providing validation documentation and quality assurance insights, ensuring a smooth process during audits and inspections. Collaborate effectively with cross-functional teams, guiding them on validation tasks and ensuring alignment with best practices, while demonstrating strong interpersonal and conflict resolution skills. Handle software change management tasks, ensuring that changes comply with regulatory requirements and internal quality standards. Work as an individual contributor, without direct reports, yet maintaining strong teamwork skills and contributing to a positive, collaborative environment. Qualifications & Experience: A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred. Hands-on experience with computer system validation deliverables. Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered. Knowledge of software change management and regulatory compliance standards. Benefits: Family health insurance Excellent pension scheme Life assurance Career development opportunities State-of-the-art facility Growing business with access to additional benefits For a confidential discussionandmore information on the role,please contactKevin Griffin Skills: Validation Change Management Software Validation