Curriculum Vitae

Quality Manager & Regulatory Compliance Analyst — Verona, WI

• —Conducted internal audits of QMS processes governing software design, development, and post-market activities, evaluating procedural adherence, documentation completeness, and regulatory alignment against FDA, ISO, EU MDR, and Health Canada standards.
• —Prepared audit reports with structured findings, regulatory references, and corrective action recommendations; performed follow-up audits to verify sustained implementation.
• —Reviewed software requirements and user stories before each development cycle, translating specifications into structured validation approaches.
• —Participated in design reviews and feature planning discussions, contributing analysis that directly influenced developer decisions.
• —Contributed to the design of a psychiatric safety-check reporting dashboard by working directly with clinicians and developers to define reporting requirements and surface workflow gaps.
• —Validated front-end clinical data entry against the psychiatric safety-check reporting dashboard, confirming that safety documentation translated accurately into leadership-visible reporting outputs; testing findings delayed one release to ensure patient-safety integrity.
• —Collaborated with software developers, clinical SMEs, and product stakeholders across design reviews, feature planning, and defect resolution.
• —Integrated AI tools (ChatGPT, Claude) into compliance documentation, test plan development, audit support, and technical writing workflows.
• —Coauthored published op-ed in STAT News on suicide screening practices with Geoffrey Engel, M.D., Ph.D., and J. Wesley Boyd, M.D., Ph.D.