Post-Market Quality Specialist

Remote – Chicago, IL        ·         Full time

Location – Chicago, IL | Coralville, IA | or Remote-US 

Digital Diagnostics is looking for a results-oriented quality assurance professional who is focused on getting things done.  The Post-Market Quality Specialist will be responsible for implementing and following processes associated with Digital Diagnostics’ post-market surveillance activities.

This position reports to the Director of Quality Assurance.  This role collaborates with teams across the organization including Engineering, Product, Customer Experience, Regulatory, Clinical, and IT.  The Post-Market Quality Specialist will:

• Act as the primary Quality Assurance resource for the timely identification and evaluation of customer feedback and complaints.
• Coordinate across the organization to ensure a robust evaluation and disposition of complaints.
• Trending and reporting on complaints.
• Identify potential product and process non-conformances.
• Coordinate with Regulatory Affairs to ensure appropriate vigilance reporting.
• Initiate and manage product and process-related CAPA’s.
• Maintain current knowledge of post-market surveillance requirements and best practices.
• Report on complaint metrics at periodic quality management reviews and other meetings.
• Develop and offer periodic training on employees’ obligations regarding complaints.
• Assist with quality audits and inspections by regulatory agencies and other external parties.
• Perform other quality-related duties as assigned.

What You’ll Bring to the Team

• Bachelor’s degree in a technical, life science, or healthcare discipline or equivalent experience.
• A minimum of 3 years of experience in a Quality Assurance role in the medical device industry, with at least 1 year of experience in a complaint processing role.
• Working knowledge of medical device quality system regulations (21 CFR 820, 21 CFR Part 803, 21 CFR Part 806, EU MDD/MDR) and standards (ISO 13485, ISO 14971).
• Ability and willingness to work independently and take initiative to ensure timely action on complaints.
• Ability to adapt to new challenges, learn quickly, and take action while engaging in a fast-moving, growing startup environment.
• Competency with MS Office Suite (Word, Excel, Powerpoint).
• Occasional travel (<10%) may be required.

What Will Help You in This Role

• Working knowledge of the Corrective and Preventive Action (CAPA) process.
• Working knowledge of the product nonconformance process.
• Experience with medical device software products (SaMD).
• Skilled at identifying trends in data and using visualization tools to effectively communicate information.
• Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE) or similar designation.

What We Have to Offer

• Supportive and flexible work environment.
• Remote-friendly culture.
• Access to competitive benefits.
• Mission-driven teammates who are working to tackle complex challenges to help improve the accessibility and quality of medical diagnosis.
• Core behaviors that inspire day-to-day interactions.
• Dedication to career growth and development of our team members through mentorship programs and defined growth paths.  
• Virtual social and wellness events.  

Who We Are

Digital Diagnostics Inc. is a pioneering AI diagnostics company on a mission to transform the quality, accessibility, equity, and affordability of global healthcare. We pursue our mission through the application of technology in the medical diagnosis and treatment process. The company, originally founded by Michael Abramoff, MD, PhD, a neuroscientist, practicing fellowship-trained retina specialist, and computer engineer, is led in partnership with co-founders, John Bertrand, and Seth Rainford. Digital Diagnostics’ first FDA De Novo cleared autonomous AI system, IDx-DR, is already improving patient outcomes by detecting diabetic retinopathy (including macular edema) at the point-of-care.   

Digital Diagnostics is paving the way for autonomous AI diagnosis to become a new standard of care, contributing to democratizing healthcare and closing care gaps. The company works closely with patient advocacy groups, federal regulators, and other quality of care and ethics-focused stakeholders to enable adoption of autonomous AI.  For more information and the latest news follow: https://digitaldiagnostics.com/ 

What We Believe  

At Digital Diagnostics, we’re doing “AI the right way” by building healthcare solutions that are safe, equitable, and accessible. We’re not only building a platform; we’re also building a community that emulates these values. We believe that inclusion and equity in healthcare start with a community of collaborators that celebrates human differences including race, ethnicity, gender, age, sexual orientation, human need, veteran status, political affiliation, and religion. We value what makes each person unique and create a place for everyone to thrive as we build towards shared goals. We’re committed to continuous learning and are striving to create a principled workplace while continuing to impact the world around us. 

This position can be located anywhere in the United States. We are not currently accepting applications for candidates located in countries outside of the U.S. Unfortunately, we are not able to sponsor an immigration case for employment at this time (for example, H-1B or other employment-based immigration cases).

Please click here to apply.