Sheena Dent

About Sheena Dent

I am a Quality Specialist with over 7 years of experience in the medical device and regulated industries, with expertise in document control, CAPA management, risk analysis, and regulatory compliance. Skilled in ensuring adherence to FDA 21 CFR 820, ISO 13485, GMP/GDP, and audit readiness, I thrive in environments that demand accuracy, efficiency, and cross-functional collaboration.Throughout my career, I have: • Led CAPA investigations and root cause analyses to prevent recurring issues and strengthen compliance. • Administered MasterControl QMS for document workflows, training records, and audit support. • Supported process validation (IQ/OQ/PQ) and document lifecycle management to ensure regulatory alignment. • Partnered with R&D, manufacturing, and quality teams to streamline operations and improve product reliability.I am passionate about advancing patient safety and product quality by driving continuous improvement in quality systems and ensuring organizational readiness for audits and inspections.

Experience

1. Millstone Medical Quality Specialist, Training & Compliance

   Millstone Medical

   Jun 2023 — Present · Memphis, TN, US

   Develop and manage compliance-focused training programs aligned with SOPs and regulatory requirements. • Maintain MasterControl records, user accounts, and compliance reports to ensure audit readiness. • Support quality initiatives through CAPA tracking, error resolution, and documentation review.