Smatha Denby

About Smatha Denby

Quality systems and post‑market quality leader with 8 years of experience in medical device and SaMD environments, specializing in complaints, CAPA, risk management, and QMS optimization under ISO 13485, 21 CFR 820, IEC 62304, and ISO 14971. I have owned end‑to‑end complaint and feedback processes, managed CAPA systems back to 100% on‑time performance, and led internal audit programs. I enjoy leading teams through complex issues with calm, solutions‑focused communication, turning data from complaints, audits, and risk files into actionable improvements for patients, users, and the business. Open to Quality Systems Manager, Sr Quality Manager, Complaints/Post‑Market Manager, and similar roles in Nashville or fully remote.

Experience

1. Quality Systems and Risk Manager

   Turing Medical

   Mar 2024 — Present

   Own the end to end complaints and feedback process, including intake, triage, investigation, risk assessment, decision making, and final closure- Implemented formal escalation protocols and timeliness goals, reducing investigation and disposition time and consistently meeting or exceeding timeliness KPIs- Serve as final reviewer and approver for complaints, with standardized GFE process and closure rationales, ensuring linkage to product problem reports and CAPA- Designed and implemented new complaint and CAPA metrics and dashboards (timeliness, volume, defect categories) for management review and risk oversight- Performed complaint trend analysis that identified a recurring failure, escalated, and triggered investigation of a coding error and CAPA- Oversee all CAPAs, complaint records, feedback, bug tickets, NCMRs, RMAs, and product problem reports; led remediation of CAPA, complaint, and feedback processes to restore full compliance and achieve 0 late CAPA phases with 100% on-time performance- Implemented tracking systems for CAPAs and complaints, improving first-time-right completion to 95%- Lead the cross-functional Issues team and CAPA Review Board, driving root cause analysis and timely closure of post-market issues- Plan and lead the internal audit program (including the 2025 internal audit), define schedules and personnel for quality system and supplier audits, and support front room/back room inspection activities- Serve as risk liaison for SaMD development and lifecycle, managing risk files to ISO 14971, IEC 62304, and IEC 60601 and supporting closure of four product lifecycles and related submissions- Optimize eQMS and issues modules, reduce tracking time by 25%, lead change control, maintain metrics, and guide the QA team while fostering a calm, solutions focused culture-

Education

• Middle Tennessee State University (MTSU)

  Bachelor of Science - BS, Criminal Justice

  2016

• Strayer University

  Master of Business Administration - MBA, Finance, General