Quality Systems Analyst - QMS, SaMD & AI

Location

Remote (USA) Commitment: Part-time, 10–20 hours per week Type: 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 specialized consulting. Alongside our physician network, we partner with regulatory, quality, and technical experts who support companies building the next generation of healthcare technology.

About the Role

We're looking for a Quality Systems Analyst to design, automate, and optimize an audit-ready Quality Management System (QMS) for digital health and AI products. You'll set up low-friction QMS processes for Software as a Medical Device (SaMD) and build quality controls into modern software engineering workflows without losing regulatory defensibility. Your job is to connect regulatory requirements (ISO 13485, ISO 14971, IEC 62304) with modern CI/CD pipelines.

Responsibilities

• Develop the most efficient ways to use the QMS to meet regulatory expectations
• Build a quality system that meets audit-ready standards
• Simplify design controls to minimize friction for developers and development pathways
• Explore how AI can be applied to meet QMS compliance requirements
• Test new approaches for capturing software changes and design controls in compliance with regulations
• Show internal stakeholders, health authorities, and auditors that the QMS data is defensible and reliable

Requirements

• Advanced degree in Engineering, Computer Science, Operations, or a related field
• 8+ years in Quality Engineering, Systems Architecture, or Design Assurance for SaMD or digital health products
• Proven track record setting up automated QMS processes from scratch, not only 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 set up design controls that keep developer friction low while staying compliant
• Must be based in the United States

Nice to Have

• Experience with LLMs, prompt engineering, or AI-agent architectures
• Experience defending novel software quality approaches in Notified Body or US FDA audits
• Cross-functional leadership driving cultural shifts toward automation
• Experience working with global health authorities or standards bodies

What We Offer

• Competitive pay based on experience and qualifications
• Flexible, part-time schedule (10–20 hours/week)
• Fully remote within the US
• Work on new SaMD and AI healthcare products

Interested? Apply now!

Work Location: Remote