Qureight

QA Engineer

• - Lead the development and execution of Qureight’s regulatory strategy, ensuring alignment with global standards and business objectives.
• - Drive regulatory submissions and clearances for SaMD, AIaMD, and biomarker validations, acting as the primary liaison with regulatory authorities (e.g., FDA, MHRA, etc) and notified bodies.
• - Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets.
• - Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems and processes are compliant.
• - Stay ahead of emerging regulations and AI guidance, proactively adapting Qureight’s strategies to maintain a competitive edge.
• - Revolutionise Qureight’s quality processes and systems, implementing best-in-class frameworks to enhance efficiency, compliance, and scalability.
• - Ensure all clinical operations adhere to ICH-GCP guidelines (R2/R3), applicable regulations, and internal quality standards.
• - Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF) to support GxP compliance and operational excellence.
• - Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively.
• - Partner with Clinical Operations, IT, Engineering, and Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems.
• - Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies.
• - Support the Quality Manager in maintaining the Business Management System (BMS) as it relates to GCP and clinical operations.
• - Develop and track quality objectives and performance metrics, aligning them with organisational goals and regulatory expectations.
• - Oversee a robust risk management framework that ensures proactive identification, assessment, and mitigation of quality and compliance risks across all operations.
• - Drive a data-informed approach to continuous improvement, leveraging quality metrics, trends, and industry benchmarks to shape strategic priorities and operational excellence.
• - Champion a risk-based quality culture, ensuring accountability, transparency, and resilience in all processes, systems, and teams.
• - Ensure the organisation anticipates and adapts to evolving regulatory and quality challenges, maintaining agility and compliance in a dynamic environment

Head of Quality Assurance and Regulatory Affairs

• Help implement testing strategies across Qureight’s integrated software stack, including automated unit, integration, regression and E2E tests.
• Ensure that all functional, performance, regulatory, privacy and security requirements are tested to an acceptable level prior to product release.
• Manage test runs; identifying, reporting and tracking any software defects that arise.
• Participate in software design reviews, helping to ensure that all software requirements are clear, concise and testable.
• Contribute to the ongoing improvement of automated processes that produce traceable artefacts.
• Attend sprint planning and stand-up meetings to stay apprised of new feature development work
• Contribute to risk-based computer systems validation (CSV) across a range of commercial and in-house software platforms to ensure compliance with clinical trial, quality and regulatory standards, particularly Good Clinical Practice and GAMP 5.
• Be proactive in suggesting improvements that improve product quality and our way of working.
• Remain up to date with the latest best practices and testing methodologies and frameworks.

Head of Quality Assurance and Regulatory Affairs

Software Validation Engineer, QA