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Dixita AminDA
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Dixita Amin

@dixitaamin

Quality Assurance Team Lead at Abbott Diagnostics who led a team of 10 and achieved zero critical audit findings.

United States
Message

At Abbott Diagnostics, I directed QA operations in an FDA-regulated, ISO 13485-certified facility and led and evaluated a team of 10 QA specialists. Our external audits had zero critical observations, and I reported quality KPIs to leadership.

I investigated complaints involving COVID-19 and influenza products, connected findings to CAPA and field actions, and maintained 100% on-time MDR/Vigilance submissions. I also worked with EU and APAC teams on complaint, vigilance, and field action activities.

Before Abbott Diagnostics, I managed hospital operations and performance improvement at CENTRAL FLORIDA INPATIENT MEDICINE. My M.D. training informs my work applying quality systems and regulatory requirements to patient safety and product quality.

Experience

Work history, roles, and key accomplishments

Abbott Diagnostics logoAD

Quality Assurance Team Lead

Jan 2021 - Dec 2025 (4 years 11 months)

Directed QA operations in an FDA-regulated, ISO 13485-certified facility, ensuring compliance with 21 CFR Part 820 and ISO 14971. Led a team of 10 QA specialists, maintained 100% on-time MDR/Vigilance submissions, and achieved zero critical audit findings.

Education

Degrees, certifications, and relevant coursework

WM

Windsor University School of Medicine

Doctor of Medicine, Medicine

2005 - 2013

Earned a Doctor of Medicine degree, transitioning from clinical practice to quality assurance and applying medical training to strengthen patient safety and regulatory compliance.

Tech stack

Software and tools used professionally

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