IDx is looking for a highly driven, detail oriented individual to help manage our quality assurance and regulatory compliance efforts. Working in a team setting, the candidate will lead development, implementation, and maintenance of the company’s quality systems and policies. They will aslo have an opportunity to understand – and, in some cases, help to inform the development of – the regulatory and legal procceses for clearing state-of-the art software devices through FDA and other government bodies. By understanding, communicating, training, and enforcing compliance standards, our Quality Assurance Manager will help accomplish IDx’s core quality assurance and business objectives.
This particular role requires affinity with Quality Assurance and ISO-standard/FDA compliance, or work in a similarly detail-oriented field. IDx operates within the regulated medical device industry and is following a highly structured development process that requires extensive documentation and record keeping.
Bachelor’s degree or higher (JD preferred)
Experience working with complicated regulatory standards or direct work experience in a strictly regulated industry such as medicine, aerospace, automotive, or legal
Exceptional analytical and organization abilities
Ability to derive joy from navigating complicated regulatory frameworks
Obsessive attention to detail
Genuine commitment to team work in a fast-paced, entrepreneurial environment
Desire to own decisions and take responsibility for outcomes
Strong verbal and written communication skills
Applicants must not now or in the future need IDx to sponsor an immigration case for employment (for example, H-1B or other employment-based immigration cases).
What will help you in this role:
Experience with ISO/CE certification processes, US and relevant international medical device regulations, and QMS maintenance and QMS audits
IDx is executing a plan to implement the first fully-automated artificial intelligence (AI) diagnostics in US healthcare. Built on a series of patented machine learning algorithms, our software is designed to automatically diagnose early signs of various debilitating eye diseases, helping prevent blindness, drive down healthcare costs, and transform the way the world thinks about disease detectio...n.
IDx is a private company with substantial funding and a deep product pipeline. As a small, high-growth company, every member of our team plays a fundamental role in ensuring our success. We want to hire people who bring new skills and perspectives that will take us to the next level. For more info, visit eyediagnosis.net/careers.