US QMS Analyst

United States . Remote

Project summary

We are looking for a QMS Analyst to help design, automate, and optimize an audit-ready Quality Management System for next-generation digital health and AI products. In this role, you will re-imagine traditional compliance pathways, embedding QMS controls into modern software engineering workflows while maintaining full regulatory defensibility.

Project details

This initiative focuses on setting up automated, low-friction QMS processes from scratch for Software as a Medical Device (SaMD) and complex digital health tools. You will bridge the gap between regulatory requirements (ISO 13485, ISO 14971, IEC 62304) and modern CI/CD software pipelines.

Responsibilities

Your responsibilities will be:

Participate in developing the most efficient way to use QMS to meet regulatory expectations.
Create a system that can meet audit-ready standards.
Simplify design controls to provide the least amount of friction to developers and development pathways.
Reimagine how QMS can be achieved using AI to meet compliance requirements.
Experiment with novel approaches for capturing software changes and design controls to comply with regulatory requirements.
Prove the defensibility and reliability of QMS data to internal stakeholders and external health authorities/auditors.

Requirements

Minimum Qualifications:

Advanced degree in Engineering, Computer Science, Operations, or a related field.
8+ years of experience in Quality Engineering, Systems Architecture, or Design Assurance specifically 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 with modern software architecture, CI/CD pipelines, and version control.
Ability to establish design controls that provide minimal friction to developers while maintaining compliance.

Preferred Qualifications:

Experience 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 driving cultural shifts toward automation.
Experience engaging with global health authorities or standards bodies.

Compensation

For your valued time and insights, competitive hourly compensation will be provided based on experience and qualifications.

Interested in this role? Use Apply now above or email recruiting@medcase.health with questions. Our team will follow up with more information.

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Designed for Practising Clinicians

Medcase engagements are built to complement active clinical practice—not replace it.

Project-based participation aligned with your specialty
Compensation for professional medical expertise
Flexible involvement without long-term commitments
Secure, compliant environments (HIPAA, GDPR)

Held to Clinical Standards

Not every contribution is equal in healthcare—and we treat it that way.

Credential verification and specialty matching
Structured review and calibration processes
Ongoing quality oversight by medical and project leads
Clear clinical and ethical guidelines

How Clinicians Contribute

Clinicians participate where medical judgment matters most in AI development.

Reviewing and validating medical data and model outputs
Providing expert clinical interpretation across modalities (text, imaging, video, waveform, audio)
Supporting clinician-led data annotation and enrichment
Advising on clinical accuracy, relevance, and edge cases
Contributing specialty-specific insight across regulated use cases

Professional Contribution, Fairly Compensated

Clinicians are compensated for their time and professional expertise.

Compensation details are shared transparently during the application and onboarding process
Participation is designed to fit alongside active clinical roles

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