Smatha Denby
@smathadenby
Quality systems and regulatory leader specializing in medical devices and SaMD, driving compliance and process improvement.
United StatesWhat I'm looking for
I am a versatile Quality & Regulatory leader with eight years of experience in medical device and SaMD environments, working across large corporations and startups to own eQMS, CAPA, complaint handling, and regulatory readiness.
At Turing I led CAPA and complaint systems to 0 late CAPA phases and 100% on-time CAPA performance while improving first-time-right completion to 95%, managed risk for SaMD lifecycles, and served as ZenQMS administrator to streamline workflows and reduce tracking time by 25%.
Earlier roles at Olympus/RQM+ and Philips refined my skills in MDR reporting, large-scale complaint remediation, team leadership, audit readiness, and KPI-driven process improvements, and I hold an MBA and ISO 14971 risk management certification to support strategic quality initiatives.
Experience
Work history, roles, and key accomplishments
Quality Systems and Risk Manager
Turing Medical Technologies, Inc.
Mar 2024 - Present (1 year 11 months)
Oversee CAPA, complaints, NCMRs, RMAs and risk management for SaMD and devices, achieving 0 late CAPA phases and sustaining 100% on-time CAPA performance while improving first-time-right completion to 95%. Led internal audit program, ZenQMS administration, change control, dashboards and cross-functional issues team to reduce tracking time by 25%.
Quality Specialist Consultant
RQM+
Oct 2021 - Mar 2024 (2 years 5 months)
Evaluated T1–T4 complaints and led a 3-year retrospective review to identify complaints and complete FMEAs, filing 1,100 MDRs and sustaining a 98% on-time MDR submission rate while remediating backlog across multiple systems.
PHManaged teams of offshore complaint investigators and improved complaint coding accuracy to 95%, increased actionable customer feedback by 30%, and drove SOP revisions and process improvements that improved efficiency by 15%.
PHLed an onshore team of 18 evaluators managing ~150 complaints across imaging modalities, increased quality-check pass rate by 20%, and ensured KPI reporting and continuity of operations during SRRT transition.
PHEvaluated ~100 service events daily to identify complaints and safety incidents, supported implementation of a new QMS across US and Europe, and developed training to improve evaluation consistency and documentation.
Education
Degrees, certifications, and relevant coursework
SUStrayer University
Master of Business Administration, Finance
Master of Business Administration with a concentration in Finance from Strayer University in Nashville, TN.
MUMiddle Tennessee State University
Bachelor of Science, Criminal Justice
Bachelor of Science in Criminal Justice from Middle Tennessee State University in Murfreesboro, TN.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring Smatha?
You can contact Smatha and 90k+ other talented remote workers on Himalayas.
Message SmathaFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
