Imagen enables Primary Care providers to become technology-enabled multispecialty practices, powering a successful transition from fee-for-service to value-based care. Imagen’s comprehensive platform includes in-office diagnostic testing, diagnostic interpretations powered by proprietary FDA-cleared machine learning software, and virtual specialist consults. Imagen’s platform empowers Primary Care providers to achieve healthcare’s quadruple aim of increasing quality, lowering costs, and improving the patient and provider experience. 

Imagen’s team includes over 100 clinical, technical and business personnel. Imagen’s software has received first-of-its-kind FDA clearances, and its research has been published in leading peer-reviewed journals. Imagen has raised $135 million in capital from investors such as Google Ventures, Casdin Capital, and Threshold Ventures. Imagen was founded in 2015 and is based in New York City.

We’re looking for a Senior Quality System Specialist to support activities related to the development, distribution, and maintenance of AI-enabled medical device software. In this role, you’ll be a key contributor in establishing, improving, and measuring the suitability and effectiveness of a growing Quality Management System. This is a great opportunity for an individual looking to contribute their quality system expertise in a fast-paced, innovative health-tech startup! 

Responsibilities:

• Provide oversight, expertise and guidance for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with established internal and external standards and guidelines.
• Participate in Risk Management, Design Verification and Validation, Transfer, and Change activities. 
• Contribute quality support for CAPAs, nonconformance reports, and other responses to quality system issues identified. 
• Participate in audit and inspection preparation, owning resolution of audit and inspection findings as appropriate. 
• 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; analyze metrics and create reports as needed. 

Qualifications:

• Bachelor's Degree in Physical Sciences, Life Sciences, or Engineering or have commensurate work experience in a regulated industry.
• 4+ years experience working with quality systems in medical device organizations.
• Knowledgeable in FDA and ISO guidance, regulations, and standards such as 21CFR820, ISO 13485, ISO 14971, and IEC 62304. 
• Strong communication and organizational skill, technical problem solving, the ability to work independently and in teams, critical thinking, the ability to adapt in a rapidly changing environment, and the desire to contribute to impactful and innovative products. 

Nice to have:

• Experience working with SaMD and software validation of off-the-shelf tools.
• Familiarity with eQMS software and commonly used programs such as Microsoft, Google Workspace, and Minitab

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.