Software Developer and Quality Specialist

About the job & opportunity

In the role of a Software Developer and Quality Specialist, you will be responsible for software development, maintenance, and the production and maintenance of documentation created during the product development process. In this role, you will work closely with the product development team and quality management to ensure that software-related processes and documentation meet the requirements of ISO 13485, IVDR, ISO 62304, and other relevant software standards. 

Responsibilities: 

• Development and maintenance of software, ensuring functionality, performance, and safety. 
• Participation in software development planning, implementation, testing, and quality management throughout the development lifecycle. 
• Ensuring that the software complies with software standards, safety requirements, and adheres to ISO 13485, IVDR, QSR, and IEC 62304 standards. 
• Involvement in compliance assessment and risk management processes, ensuring the software meets safety and performance requirements. 
• Creating and maintaining quality documents required for development, such as risk analyses, design requirements, and testing and validation reports. 
• Updating documentation related to software changes, ensuring traceability and auditability of modifications. 
• Working closely with the quality management team and other stakeholders to meet internal and external requirements. 
• Supporting internal and external audits and maintaining related documentation. 

Required Skills and Experience: 

• Extensive experience in software development and lifecycle management, including design, implementation, testing, and maintenance. 
• Strong skills in programming languages and software design principles, especially in regulated fields requiring high functionality, performance, and safety. 
• Extensive experience in at least some of the following technologies in software development: 
• Mobile: iOS, Android, React Native, BLE, Serial connection 
• Frontend: React, Typescript, TanStack Query 
• Backend: .NET Core, C#, Entity Framework, Azure DB 
• Servers: Azure 
• Experience in complying with software quality and safety standards, as well as in compliance and risk management assessment processes, particularly in regulated software production (ISO 13485, IVDR, QSR, and IEC 62304) with a focus on safety and performance requirements. Ability to create, maintain, and manage documentation from a quality management, risk management, and compliance perspective. 
• Experience in technical writing and document management tools to ensure traceability and auditability of changes. 
• Strong collaboration and communication skills, including the ability to work with quality management, development teams, and other stakeholders to meet project requirements. 
• Experience working in teams on regulated projects, such as audits and ensuring compliance throughout the development process. 

Preferred Qualifications: 

• Previous experience with healthcare software or in vitro diagnostics. 
• Education in software engineering, computer science, or a related field. 
• Previous experience working in a regulated environment, such as ISO 13485, IVDR, QSR, and IEC 62304.