Quality Assurance Engineer
We are a healthcare AI nonprofit startup focused on developing innovative solutions to combat COVID-19. Our mission is to leverage artificial intelligence and machine learning to create a mobile application that can detect the presence of COVID-19 through analysis of cough sounds. We are committed to improving public health and safety by providing accurate and accessible tools for early detection and prevention of infectious diseases.
Assist in developing and implementing quality control processes for the COVID-19 detection app. Conduct testing and analysis of the app's performance to ensure accuracy and reliability. Collaborate with the development team to identify and address any quality issues or bugs. Participate in the design and execution of software validation activities. Conduct research and stay up to date with relevant regulatory requirements and standards in the healthcare industry, particularly in the field of medical software. Assist in preparing and maintaining regulatory documentation, including technical files and design control records. Support the regulatory team in submitting necessary documentation to regulatory authorities for approvals and clearances. Collaborate with cross-functional teams to ensure compliance with applicable regulations and standards. Identify areas for process improvement within the quality and regulatory functions. Propose and implement enhancements to streamline quality control and regulatory compliance processes. Contribute to the development and documentation of standard operating procedures (SOPs) to ensure consistency and efficiency. Collaborate with the development, data science, and user experience teams to gather feedback and requirements for quality improvements. Communicate effectively with team members, providing updates on project progress and discussing potential issues or challenges. Assist in conducting training sessions or workshops to ensure awareness and adherence to quality and regulatory standards.
Currently pursuing a Bachelor's or Master's degree in Biomedical Engineering, Electrical Engineering, Computer Science, or a related field. Strong interest in healthcare technology, AI, and machine learning. Familiarity with quality control methodologies and processes. Knowledge of regulatory requirements and standards in the healthcare industry (e.g., FDA regulations, ISO standards) is a plus. Excellent analytical and problem-solving skills. Strong attention to detail and the ability to work independently. Effective communication and interpersonal skills. 