Quality System Specialist

About Medical Informatics Corp. Medical Informatics Corp. (MIC), based in Houston, Texas, has been advancing healthcare technology for over 10 years. MIC’s mission is to deliver next-generation technologies that unify patient monitoring workflows for healthcare systems, helping clinicians securely access and use continuous data at the point of care. Guided by our vision - Every patient. Everywhere. Monitored by people who care. Empowered with actionable data. - MIC’s FDA-cleared Sickbay Clinical Platform aggregates, time-synchronizes, and redisplays data from diverse bedside devices into a vendor-neutral, centralized dashboard within an interoperable system. This scalable solution supports clinical decision making, remote monitoring, advanced analytics, and AI-enablement, while meeting the highest standards for compliance, security, and patient safety. MIC’s innovative team of engineers, clinicians, researchers, and more work alongside hospitals and healthcare systems across the country to develop groundbreaking discoveries to create a new standard of software-based monitoring and data-driven care. Location: This position is remote, with organizational alignment to our headquarters in Houston, TX. Role Overview The Quality System Specialist supports Quality Management System (QMS) processes, including audits, CAPA, supplier management, and compliance documentation to ensure regulatory readiness and continuous improvement. Duties and Responsibilities Internal Audit Management Lead and support the planning, execution, and documentation of internal audits in alignment with audit standards and organizational risk priorities Develop and prepare audit materials, and oversee the collection and evaluation of audit evidence to ensure accuracy and completeness Maintain comprehensive and well-organized audit documentation and records to support findings and regulatory requirements Monitor, track, and report audit findings, ensuring timely remediation and closure of corrective actions Drive cross-functional coordination to address audit findings, ensuring alignment with regulatory, compliance, and internal control requirements Provide guidance to stakeholders on risk mitigation strategies and control improvements CAPA & Nonconformance Management Manage and track CAPAs, including initiation, root cause investigation, corrective action planning, and effectiveness verification. Ensure CAPAs are documented, progressed, and closed within required timelines. Support investigation and documentation of nonconformances and ensure proper escalation where required. Maintain traceability between nonconformances, CAPAs, and related documentation. Product Development & Design Control Duties Compile and maintain the Software Nonconformance (NC) log, ensuring accurate tracking, status updates, and reporting. Ensure completeness and compliance of Design History Files (DHF) and related documentation within the eQMS. Support cross-functional teams in ensuring design documentation aligns with internal procedures and regulatory requirements (e.g., IEC 62304, ISO 13485). General Compliance Support 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 degree in Computer Science, Engineering, or a related technical field, or equivalent experience. 4+ years of work experience in the medical device industry (SaMD preferred). 2+ years experience with regulatory standards including ISO 13485:2016, ISO 14971:2019, and 21 CFR 820. 2+ years of experience in Software Product Development and Technical Writing. Demonstrated experience executing and participating in internal/external audits and CAPA Management. Strong verbal and written communication skills, with proven capability to develop, review, edit, and proofread technical and regulatory compliance documentation. Strong organizational, time management, and project management skills, with a high attention to detail and the ability to manage multiple concurrent priorities independently and collaboratively across cross-functional teams. Proficient in learning and utilizing new technologies and tools, including GitHub, Confluence, Greenlight Guru (eQMS), Smartsheet, and Google Workspace. Preferred Skills: Professional certification in Quality, Compliance, Internal Auditing (ISO 13485:2016 Certified Internal Auditor ASQ Training), or Regulatory Affairs experience. Experience with Greenlight Guru (eQMS platform), GitHub, and Smartsheet. Demonstrate a basic understanding of computer software product 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.