Diana Sofia Ramirez Villamil

ad4fyg@r.postjobfree.com Mobile 305-***-****

Experience

Medtronic Remote

Supply Quality Engineer (contingent) May 2022 – Present

• Support EU MDR remediation and implementation projects, ensuring compliance with quality standards and Quality Management System (QMS).

• Demonstrate expertise in establishing and maintaining robust communication channels with suppliers to ensure strict adherence to regulatory requirements governing medical devices.

• Proficiently create, manage, and customize supplier control documentation to ensure adherence to Quality Management Systems and meet critical implementation deadlines. University of Miami Health System - Promote 2 Prevent Miami, Florida Counselor August 2020 – August 2021

• Operated a walk-in clinic during regular business hours, offering HIV testing services and providing guidance on treatment options.

• Demonstrated commitment to care by offering counseling and referrals for vital services, including PrEP/n-PEP, women's health and education.

• Engaged extensively with the local community by conducting HIV testing at schools, businesses, and health fairs. Organized and facilitated educational workshops targeting students and employers to raise awareness about HIV prevention and treatment.

University of Miami – Medical Campus Miami, Florida Research Assistant January 2020 – December 2021

• Collaboratively worked towards achieving groundbreaking scientific advancements in pursuit of a cure for paralysis.

• Conducted advanced molecular biology techniques: Site-directed mutagenesis and real-time PCR on rodent models, alongside maintaining primary neuronal cell cultures.

• Maintained meticulous research records: record all research activities with precision and accuracy. Analyzed PCR data to identify genes associated with functions and evaluated statistical results to inform future research directions.

• Engaged in activities to advance regulatory science: Actively contributed to initiatives promoting regulatory science knowledge, fostering stakeholder collaborations, and shaping a science-driven approach to material regulation in alignment with FDA standards.

Project

Vein viewer

• Conducted market and technology research.

• Programmed MATLAB-based Arduino interface for improved vein visualization.

• Designed and 3D-printed custom-fit prototypes for upper arms.

• Thoroughly tested prototypes to meet FDA standards, while exploring innovative enhancements. Education

University of Miami Miami, Florida

B.S.E Biomedical Engineering

Skills & Interests

Technical: C++, Matlab, Arduino, SQL, SolidWorks, PowerBI, Agile, Enovia, 21CFR120regulation, ISO1345 management system ISO14979, risk management standard ISO10993 Biocompatibility standard, CRISPR-CAS-9. (see more certification on LinkedIn)

Language: Native Spanish Speaker, English Advanced, French Intermediate Laboratory: Data Analysis, Gel electrophoresis, Chromatography (HPLC, GC, TLC), PCR and RT-qPCR, Cell culture (aseptic technique), DNA, RNA, and protein extraction, Immunohistochemistry (IHC) Interests & Activities: Society of Women Engineers, Biomedical Engineer Society & Chemistry Society Click or Scan for LinkedIn

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