Sophia Abraham

About Sophia Abraham

Clinical quality and quality engineering professional with 8+ years of experience leading and strengthening GCP and broader GxP compliance, clinical trial oversight, and inspection readiness across startup and growth-stage MedTech environments. With a foundation in biomedical engineering, I bring a cross-functional perspective shaped by experience in both clinical quality and product quality engineering, including development and maintenance of ISO 13485-compliant quality management systems and supporting quality and regulatory activities contributing to Class II and Class medical devices, including PMA programs.My experience includes clinical audits, vendor and CRO oversight, risk management, and hands-on preparation for FDA, Notified Body, and BIMO inspections. I’ve supported organizations through key regulatory milestones, including PMA submissions and inspection readiness activities associated with FDA and Notified Body reviews. As a certified ISO 13485 Lead Auditor with additional credentials in clinical research and medical device compliance, I bring a systems-level perspective grounded in quality engineering and clinical quality, with the ability to operate across the full device lifecycle.What motivates me most about this work is protecting patients and ensuring data integrity. Behind every protocol, audit, and quality system are real people who may ultimately be impacted by the therapies being developed, and that responsibility matters deeply to me.Outside of work, I enjoy staying active, hiking, and traveling, and I’m always up for trying something new. Whether it’s exploring a new place or taking on a new challenge, I value experiences that keep me curious and help me continue growing.

Experience

1. Senior Manager, Clinical Quality and Operations

   Cerevasc

   Feb 2026 — Present

Education

• New York Institute of Technology

  Bachelor of Science (B.S.), Biomedical Engineering