Test Manager, Digital Health & IoT (IEC 62304, ISO 13485)

Albus Health is a nocturnal biomarker company spun out of University of Oxford. We have developed Albus Home, a contactless multisensory platform that monitors a wide range of nocturnal parameters without the patients having to do or wear anything. The product incorporates state of the art sensor technology, with sophisticated machine learning and signal processing algorithms, collecting continuous, objective and accurate physiological data from the patient’s home. Albus Home is certified for use in 25 countries, and has been used to collect over 5 billion data points across a dozen physiological and environmental parameters. Our clients include some of the world’s largest pharmaceutical companies, and partners include some of the most reputed opinion leaders in respiratory medicine and beyond. Our team members have built unicorns in healthtech/biotech and are global leaders in medicine, drug development and healthcare technology. Albus Health is at an exciting growth stage at which we need to scale fast deliver to new contracts within ambitious timelines and grow to meet the industry demands for our products and services.

We are seeking an experienced and highly motivated Test Manager to lead our testing efforts for a critical software product under development. You will be instrumental in defining, implementing, and overseeing comprehensive testing strategies and processes throughout the software development lifecycle. This is a key role for a self-starter who thrives in a regulated environment and can expertly navigate software validation.

• Test Strategy & Leadership: Lead and manage the entire testing lifecycle, defining and implementing comprehensive test strategies, plans, and protocols that align 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 phases and the defect lifecycle. Provide clear and concise reporting to stakeholders on testing progress, risks, and product quality.
• Process Improvement: Continuously evaluate and improve testing methodologies, tools, and processes to enhance efficiency and maintain compliance with evolving industry best practices and standards.

• Bachelor's degree in Computer Science, Software Engineering, or a 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 ability to manage your own workload effectively within an agile team.

• Expertise with GxP and GAMP5 guidelines and their application to software development and validation is useful but not essential.
• Relevant certifications (e.g., ISTQB, CSQE).
• Experience with automated testing frameworks and tools.
• Familiarity with Agile/Scrum development methodologies.
• Exposure to Electronic QMS (Quality Management System) systems such as Ketryx, Cognidox, or similar would be a distinct advantage.
• Understanding of the various technologies involved in an Internet of Things and machine learning product: Cloud software (AWS), Embedded software and electronic devices.

• Competitive salary based on experience and qualifications.
• Preference for on-site collaboration with option for some hybrid work