Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, IEC 62304, and ISO 27001 standards. Oversee all quality control activities, ensuring compliance with regulatory requirements and internal standards. Lead and foster a culture of quality excellence. Conduct internal and external audits, identifying and mitigating risks to product quality and patient safety. Collaborate with cross-functional teams to drive continuous improvement initiatives. Manage and reduce quality-related costs while maintaining high-quality standards. Conduct risk assessments and implement risk mitigation strategies. Ensure effective management of non-conformances and corrective actions. Independently lead certification and re-certification audits to maintain compliance with necessary quality standards. Stay abreast of quality standards and industry best practices. Qualifications: Bachelors degree in a relevant field (e.g., engineering, science, quality management). Minimum of 5 years of experience in a quality management role within the medical device or healthcare industry. In-depth knowledge and practical application of ISO 13485, IEC 62304, and ISO 27001 standards. Proven experience in leading and managing quality teams. Strong analytical, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Experience in conducting audits and inspections. Proven experience in independently leading certification and re-certification audits. Proficiency in quality management software and tools. Benefits: Competitive salary and benefits package Opportunity to contribute to the development of innovative healthcare solutions Collaborative and supportive work environment Professional growth and development opportunities

We are seeking a highly skilled and experienced Technology Architect to join our Engineering department. The ideal candidate will have 10-15 years of experience in designing and implementing robust software systems - preferably Saas Products and react-native mobile apps. Roles and Responsibilities: Lead the implementations of digital health products on Avegens HealthMachine platform Collaborate with cross-functional stakeholders Analyze business requirements, assess technical feasibility, propose and implement technical solutions Mentor a team of engineers highly skilled in react-native, react.js and ruby on rails Evaluate and implement sustainable, safe use AI tools for developer productivity Provide hands-on technical guidance to software developers and support engineers Carefully review pull requests and maintain high standards of coding Define and maintain technology standards and best practices Conduct design reviews to ensure best practices are followed and anti-patterns are spotted and avoided. Work closely with the DevOps team to support the modernisation of containerised deployment, CI/CD pipelines Qualifications: - Bachelors degree in Computer Science, Engineering, or a related field - Full-stack development experience on one of the popular frameworks such as C# .Net, Java/Springboot, ROR, Django, node.js/next.js - Must have some experience of mobile app development - 10-15 years of experience in technology architecture - Strong knowledge of software development methodologies and best practices - Command on modern Javascript (especially frameworks like react, redux etc) - Excellent communication and interpersonal skills - Ability to work effectively in a fast-paced and dynamic environment - Relevant certifications (e.g. AWS Certified Solutions Architect) are a plus

Avegen is a digital healthcare company empowering individuals to take control of their health and supporting healthcare professionals in delivering life-changing care. Avegen s core product, HealthMachine , is a cloud-hosted, next-generation digital healthcare engine for pioneers in digital healthcare, including healthcare providers and pharmaceutical companies, to deploy high-quality robust digital care solutions efficiently and effectively. We are ISO27001, ISO13485, and Cyber Essentials certified; and compliant with the NHS Data Protection Toolkit and GDPR. Job Summary: Senior Software Engineer will be responsible for developing, designing, and maintaining the core framework of mobile applications for our platform. This includes tasks such as creating and implementing new features, troubleshooting and debugging any issues, optimizing the performance of the app, collaborating with cross-functional teams, and staying current with the latest advancements in React Native and mobile app development. We are looking for exceptional candidates who have an in-depth understanding of React, JavaScript, and TypeScript, can create pixel-perfect UI, and are obsessed with creating the best experiences for end users. Your responsibilities include: Architect and build performant mobile applications on both iOS and Android platforms using React Native. Work with managers to provide technical consultation and assist in defining the scope and sizing of work. Maintain compliance with standards such as ISO 27001, ISO 13485, and Cyber Essentials that Avegen adheres to. Lead configuration of our platform HealthMachine in line with functional specifications and development of platform modules with a focus on quality and performance. Write well-documented, clean Javascript/TypeScript code to build reusable components in the platform. Maintain code, write automated tests, and assist DevOps in CI/CD to ensure the product is of the highest quality. Lead by example in best practices for software design and quality. You will stay current with tools and technologies to seek out the best needed for the job. Train team members on software design principles and emerging technologies by taking regular engineering workshops. Requirements: Hands-on experience working in a product company developing consumer-facing mobile apps that are deployed and currently in use in production. He/she must have at least 3 mobile apps live in the Apple App Store/Google Play Store. Proven ability to mentor junior engineers to realize a delivery goal. Solid attention to detail, problem-solving, and analytical skills & excellent troubleshooting skills. In-depth understanding of React and its ecosystem with the latest features. Experience in writing modular, reusable custom JavaScript/TypeScript modules that scale well for high-volume applications. Strong familiarity with native development tools such as Xcode and Android Studio. A positive, can do attitude who isn t afraid to lead the complex React Native implementations. Experience in building mobile apps with intensive server communication (REST APIs, GraphQL, WebSockets, etc.). Self-starter, able to work in a fast-paced, deadline-driven environment with multiple priorities. Excellent command of version control systems like Git. Working in Agile/SCRUM methodology, understanding of the application life cycle, and experience working on project management tools like Atlassian JIRA. Good command of the Unix operating system and understanding of cloud computing platforms like AWS, GCP, Azure, etc. Hands-on experience in database technologies including RDBMS and NoSQL and a firm grasp of data models and ER diagrams. Open source contributions and experience developing your own React Native wrappers for native functionality is a plus. Qualification: BE/BTech/MS in Information Technology, Computer Science, or a related discipline.