Test Manager, Digital Health & IoT (IEC 62304, ISO 13485)
Oxford, Oxfordshire, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
Albus Health
with business requirements and regulatory standards. Compliance & Validation: Drive software validation and ensure adherence to relevant medical device regulations, including IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and ISO 13485 for quality management. Oversee the creation and review of all necessary GxP-critical validation documentation. Test Execution & Reporting: Manage the execution of all testing … related technical field. Minimum of 3 years of experience in software quality assurance and testing, with significant experience in regulated environments. Demonstrated expertise in software lifecycle processes (IEC 62304), risk management (ISO 14971), and quality management systems (ISO 13485). Strong understanding of relevant regulations such as FDA 21 CFR Part 11 and EU Annex 11. Proven … experience in developing and implementing robust test strategies, plans, and cases. Proficiency with test management tools (e.g., Xray), defect tracking systems ( Jira ), and collaboration tools ( Confluence ). Excellent communication and interpersonal skills, with the ability to lead a team and work with stakeholders. Strong analytical and problem-solving abilities with meticulous attention to detail. A self-starter with the More ❯
Employment Type: Permanent
Salary: GBP Annual
Posted: