Emilija Jakimovska
*** * ******* ***. # ****, Chicago, IL 606**-***-*** 1033 · *********@*****.***
EDUCATION
Bachelor of Science in Biomedical Engineering - Cell and Tissue Concentration Dec 2015 Illinois Institute of Technology (IIT) GPA: 3.25 Chicago, IL Doctor of Dental Surgery, D.D.S. - General Dentistry Apr 2010 Ss Cyril and Methodius University GPA: 3.13 Skopje, Republic of Macedonia Degree Evaluated to U.S. Equivalent by Educational Credential Evaluators Mar 2011 WORK AND RESEARCH EXPERIENCE
Quality and Regulatory Affairs Coordinator Mar 2019 – Present Young Innovations, Inc.
• Perform daily reviews of customer complaint cases to determine the need for MDR per 21 CFR 803
• Analyze customer complaint data to identify potential root cause trends and present to cross-functional audiences
• Initiate SCAR’s, CAPA’s and Change Control requests as needed and track to satisfactory completion
• Ensure adequate review, approvals, and training for all document changes
• Track all training is completed timely and documented appropriately as required per the training Work Center Training Matrix Quality Control Engineer Feb 2018 – Feb 2019
Avocet Polymer Technologies, Inc. Chicago, IL
• Gathered data on operations of FDA regulated products by direct communication with clinicians and vendors
• Used HPLC technique and Empower software to test, analyze, and assure quality of the product within the stated life cycle
• Analyzed product failure data and applied laboratory techniques such as spectrophotometry to address the concerns
• Presented results at the American Burn Association Annual Meeting in April 2018 Artificial Spleen as Abdominal Surgical Simulator Sep 2014 – May 2015 2nd Place Winner at the 10th Annual Biomedical Engineering Design Competition, IIT Chicago, IL Recognized by North Shore Center for Simulation and Innovation
• Led a team of four engineering students that successfully designed a spleen simulator for surgical training
• Collaborated with 10 surgeons and 25 surgical residents to validate the reduction in surgical errors using the simulator
• Used Autodesk Inventor, Rhinoceros 3D printing and CNC milling techniques
• Performed SWOT analysis and identified market trends to introduce the product to the market Digital Mobile App - Pocket Explorer Sep 2014 – Dec 2014 1st Place Winner in the User-Centered Design Competition, IPRO, IIT Chicago, IL
• Headed a development team to design a gaming app for information retrieval from a major publication
• Programmed using Fluid UI platform for rapid prototyping
• Implemented virtual pull marketing to reach the target market CLINICAL EXPERIENCE
Dental Assistant Sep 2011 – Aug 2012
Alexandra N Douvas, DDS, LTD Chicago, IL
• Worked chairside assisting family dentist with extractions, fillings, implants, local anesthesia and biopsies
• Sterilized instruments and lab equipment, exposed and processed dental X-rays
• Increased new patient flow and referrals by 15% of the overall patient number
• Utilized Patterson Dental software for practice management and clinical needs Doctor of Dental Surgery Feb 2010 – Aug 2011
Hami Akudent, DDS Skopje, Republic of Macedonia
• Managed direct patient care, evaluations, diagnoses, and comprehensive ongoing dental treatments
• Filled cavities, performed root canals, treated gum disease, gave anesthesia and performed oral surgery
• Treated 12-15 patients per day and provided quality treatment in fast pace environments ADDITIONAL
• Proficient in MATLAB, 3D CAD, PowerLab & LabChart, Microsoft Excel, PowerPoint, Word & Adobe Acrobat
• Fluent in English, Macedonian, Serbian, Croatian
• OSHA Certification (Bloodborne Pathogens Standard, Hazard Communication, Ionizing Radiation)