Imagen is extending the frontiers of medicine and artificial intelligence to improve human well-being. Our mission is to reduce diagnostic errors early in the patient experience while making care more affordable and accessible. We’re a team of leading scientists, engineers, clinicians, and industry professionals from some of the top healthcare and technology organizations across the globe. Our clinical team is composed of radiologists and surgeons from Mayo Clinic, Stanford Hospital, Hospital for Special Surgery, Boston Children’s Hospital, and other prestigious institutions. Imagen’s technical team consists of machine learning PhDs and engineers with extensive experience doing research and building technology and products at world-class organizations.

Imagen is a Series C company that was founded in 2015 and has raised $135M from leading venture capitalists, hospitals and health systems, and technology entrepreneurs. Our institutional investors include Google Ventures, Casdin Capital, and Threshold Ventures (formerly DFJ).

We’re looking for a Senior Quality System Specialist to ensure compliance to 21 CFR Part 820 through the implementation and maintenance of our Quality Management System (QMS). In this role, you’ll be a key contributor in ensuring the success of Imagen Technologies’ state-of-the-art AI-enabled medical device software. This is a great opportunity for an individual looking to contribute their quality system expertise in a fast-paced innovative health-tech startup! 

Responsibilities:

• Oversee the complaint handling and CAPA Systems, ensuring accuracy of the records and timeliness of required activities and reports 
• Independently execute internal and supplier audits, and ensure timely follow-up and audit item closure
• Maintain Quality System Logs (CAPAs, NCRs, Complaints, Supplier/Internal Audits)
• Collaborate with Cross-Functional Teams to ensure Quality System activities are completed professionally, accurately, and effectively within defined timeframes. 
• Maintain Quality System Data in an organized, retrievable manner and create reports and updates for periodic Management Review and other reports as requested
• Support Imagen Technologies in preparation for external audits and regulatory facility inspections
• Create and route quality system procedures, documents, and records within eQMS
• Foster a quality culture focused on meeting high quality, ethical and compliance standards

Qualifications:

• Mission-driven and passionate about improving healthcare outcomes
• 4+ years experience working with quality systems in medical device organizations
• Must be knowledgeable in 21 CFR 820 and ISO 13485
• Experience working with SaMD and software validation of off-the-shelf tools is highly preferred
• Detail and execution-oriented, with the ability to communicate complex ideas effectively, both verbally and in writing
• Bachelor's Degree in Physical Sciences, Life Sciences, or Engineering or have commensurate work experience in a CFR 820 environment

This role is remote or may be based in New York, NY.

Imagen is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Imagen will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.