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Quality Assurance Lead
iOS,Android,GxP,X-ray
Leveransansvarig
Gbg
The Mobile Quality Assurance Lead – Study Onboarding is responsible for leading the mobile team in validation and testing activities related to mobile product development for clinical studies using Unify—a clinical trial solution co-designed by patients, healthcare professionals, and to streamline and digitize the trial experience. This role involves close collaboration with the Product team, analyzing study-specific features and the mobile devices planned for use. The Mobile Lead ensures the overall performance, stability, and user experience of mobile phones and medical devices used in the studies, validating them under various study configurations. The Test Lead will have the opportunity to establish and maintain QA metrics and KPIs to track validation progress, identify trends, and drive continuous improvement initiatives.  Overview of responsibilities The Mobile QA Lead as part of the Study Onboarding Test team is expected to perform at Seniority level in the following:     • Team Leadership: Take full ownership of the quality and performance of mobile phones and medical devices during the study onboarding phase, ensuring they meet all specified requirements and deliver a high-quality experience. Lead the successful validation and testing of mobile and medical device components, prioritizing ongoing support and optimization of the QA process. Actively refine and improve the onboarding QA process, addressing any blockers that arise. Collaborate closely with the Product team, mobile distributors, and other stakeholders to ensure successful releases and effective integration with the clinical study.   • Validation and Testing of Mobile and Medical Devices: Plan and execute test cases for mobile phones and medical devices, ensuring thorough testing of their performance, stability, and user experience under various study configurations. Oversee and participate in testing activities to verify the quality and functionality of the devices and their integration with the study.  • Impact Assessment and Configuration Changes Analysis: Analyse study specifications and collaborate with the Business Analyst (BA) team to understand the scope and impact of new study configurations on mobile and medical devices. Assess the changes made to mobile and device configurations and lead the development of test cases and coverage to validate these changes during study onboarding.  • Risk Management: Identify and mitigate risks related to mobile and medical devices' quality during the study onboarding and upgrade processes. Proactively address potential issues to minimize their impact on project timelines and deliverables, ensuring smooth integration and functionality.      • Defect Management: Manage the identification, tracking, and resolution of defects related to mobile and medical devices encountered during testing. Ensure timely resolution of issues and effective communication with relevant stakeholders to maintain the quality and performance of the devices.  • Documentation: Ensure comprehensive documentation of QA activities, including test plans, test reports, and traceability matrices. Maintain detailed records to support project documentation and audit requirements, reflecting the quality and performance of mobile and medical devices in the study.  • Process improvement - Provide feedback on the testing process and suggest improvements to streamline Configuration Verification and Test activities for future study upgrades.    Work collaboratively with  • New Studies Onboarding QA Team – Requirement Analysis, Test Planning, Test Case Design and Execution, Defect Management, and Risk Assessment. Maintain the Onboarding documentation as test plans and test reports.  • Study Onboarding BA Team – collaboration on requirements analyses and impact assessment.  • Study Onboarding PM Team – collaborate with the PM team on planning and defect prioritization and upgrade dependencies.  • SMEs – engineering teams on case analysis and resolution. • Product owners and business analysts, to understand existing functionalities.     Required skills & experience.  • 7+ years of experience in software quality assurance, with 2 years in a leadership role  • 3-5 years of experience in mobile application or  SDK testing, demonstrating a strong understanding of Android and iOS platforms.  • Mobile proficiency: Hands-on experience with mobile devices, emulators, and simulators.  • Experience with Medical Devices  • Solid understanding of quality assurance theory, terminology, and strategies.  • Proficiency in test planning, test case design, and test execution.  • Experience with test management tools and systems such as XRay and defect tracking systems.  • Excellent communication and interpersonal skills, with the ability to effectively lead and collaborate with cross-functional teams both technical and non-technical. • Experience in mentoring and coaching team members, providing guidance and support to ensure quality deliverables.  • Mobile testing experience  • Experience in working with HTTP Proxy Tool  • Experience in integration and web-services testing.  • Excellent Task management skills and task prioritization    Desired skills & experience  • Experience from Healthcare and Life Sciences, preferably with clinical trials.  • Experience of working in a global organisation with complex/geographical context  • Experience of working in a regulated environment, ideally, GxP/SaMD experience • Knowledge of automation testing tools and experience supporting automation tests    Education • Degree in relevant discipline or formal certification in quality assurance practice    Location:   Sweden, Gothenburg (preferably 3 days in the office)

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