Quality System Analyst

About Medical Informatics Corp.

Sickbay by Medical Informatics Corp. (MIC) is an FDA-cleared, vendor-neutral clinical platform that aggregates and time-synchronizes high-fidelity time series waveform data in its native resolution from diverse medical devices such as cardiac monitors, ventilators, EEG, video, etc. It delivers near-real-time and retrospective data through a web-based interface, enabling faster clinical decisions, improved outcomes, and AI development. 

Sickbay enables the digitization and standardization of clinical workflows that are traditionally performed manually, such as documentation, event annotation, and protocol tracking. By providing full-resolution physiologic data from anywhere, Sickbay empowers clinicians and researchers to deploy powerful analytics and AI algorithms to transform patient care.

Location:This position is remote, with organizational alignment to our headquarters in Houston, TX.

Role Overview

The Quality System Analyst maintains and manages quality documentation and processes within the eQMS to support compliance, audit readiness, and operational excellence across product and supplier functions.

Duties and Responsibilities

Supplier Management Duties

• Support supplier evaluation and re-evaluation activities in accordance with supplier management procedures.
• Maintain supplier records, including qualification documentation, performance monitoring, and risk assessments.

• Assist in tracking supplier-related issues, nonconformances, and corrective actions.

• Ensure supplier documentation is complete, current, and audit-ready.

Design Control and Product Documentation Duties

• Manage and maintain Design History File documentation, ensuring completeness and compliance within the eQMS throughout the product lifecycle.

• Oversee all design control documentation, including preparation of meeting materials, documentation of design review minutes, and tracking of action items.

• Assist in product verification and validation testing activities, including regression testing for new product versions.

• Assist with the compliance review and tracking of formal Customer Feedback and Complaint handling processes, ensuring thorough documentation and accurate reporting.

General Compliance Support

• Facilitate the execution of Protected Health Information reporting procedures and compliance tracking duties related to de-identified clinical datasets.
• Support the Director of Compliance in coordinating both internal and external audits and regulatory inspections (e.g., ISO, FDA).
• Provide essential support for audit-readiness, including document retrieval, evidence preparation, and follow-up on audit findings.
• Support departmental reporting, special projects, and other cross-functional compliance duties as assigned.
• Note: This role requires approximately 5% travel.

Qualifications

• Bachelor's or Associate’s degree. A technical field of study (e.g., Computer Science, Engineering, or Technology) is strongly preferred.

• Exceptional verbal and written communication skills, with a proven ability to develop, review, edit, and proofread technical and regulatory compliance documentation.

• Superior organizational and project management skills, capable of managing multiple concurrent priorities with acute attention to detail.

• Proficiency in utilizing and rapidly learning technology platforms, including documentation and QMS tools (e.g., GitHub, Confluence, Greenlight Guru, Smartsheet, and Google Workspace).

• Demonstrated ability to work independently, exercise strong initiative, and collaborate effectively across diverse cross-functional teams.

Preferred Skills: 

• 1-5 years of related writing experience 

• Degree in Technical Communications, Computer Science, Information Technology, Engineering

• Experience with GitHub and Google Workspace

• Understanding of computer software development 

Supervisory Responsibilities:

• This position does not have supervisory duties.

The candidate(s) offered this position will be required to submit to a background investigation.

Medical Informatics Corp is an equal opportunity employer, and all qualified applicants will receive consideration for employment 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.