QMS Analyst - SaMD & AI Digital Health

Location: Remote (USA)Commitment: Part-time, 10–20 hours per weekType: Contract / Consultant About Medcase Medcase is a global marketplace that connects organizations with on-demand medical expertise. Biotech, pharmaceutical, and AI companies, as well as CROs, rely on Medcase for telehealth, data labeling, annotation, surveys, interviews, and other specialized consulting services. Our network offers language-specific physician expertise across all clinical specialties, and we also partner with regulatory, quality, and technical experts to support companies building the next generation of healthcare technology. Medcase is growing and welcomes professionals interested in shaping the future of technology-enabled healthcare consulting. About the Role Medcase is looking for a QMS Analyst to help design, automate, and optimize an audit-ready Quality Management System for digital health and AI products. In this project, you will set up low-friction QMS processes for Software as a Medical Device (SaMD), embedding quality controls into modern software engineering workflows while maintaining full regulatory defensibility. You will bridge the gap between regulatory requirements (ISO 13485, ISO 14971, IEC 62304) and modern CI/CD pipelines. What You'll DoHelp develop the most efficient way to use QMS to meet regulatory expectations.Build a system that meets audit-ready standards.Simplify design controls to minimize friction for developers and development pathways.Explore how AI can be used to achieve QMS compliance requirements.Experiment with novel approaches for capturing software changes and design controls in compliance with regulatory requirements.Demonstrate the defensibility and reliability of QMS data to internal stakeholders, external health authorities, and auditors. RequiredAdvanced degree in Engineering, Computer Science, Operations, or a related field.8+ years of experience in Quality Engineering, Systems Architecture, or Design Assurance for SaMD or digital health products.Proven track record of setting up automated QMS processes from scratch, beyond maintaining legacy eQMS platforms.Applied expertise translating ISO 13485, ISO 14971, and IEC 62304 into software-driven engineering workflows.Strong technical depth in modern software architecture, CI/CD pipelines, and version control.Ability to establish design controls that minimize developer friction while maintaining compliance.Based in the United States. PreferredExperience with LLMs, prompt engineering, or AI-agent architectures.Experience defending novel software quality approaches during audits by Notified Bodies or the US FDA.Cross-functional leadership experience driving cultural shifts toward automation.Experience engaging with global health authorities or standards bodies. What We OfferCompetitive hourly compensation based on experience and qualifications.Flexible, part-time schedule (10–20 hours/week).Fully remote within the US. Interested? Apply directly through LinkedIn!#Medcase #QualityEngineering #QMS #SaMD #ISO13485 #IEC62304 #MedTech #DigitalHealth #RemoteWork