Quality Systems Engineer

ALINA KILIC

**** *. ***** *** ***** Dr. #**** Tempe, AZ 85281 (480) 799-

**** ***********@*****.***

OBJECTIVE

Hard-working, goal oriented, innovative professional seeking to advance my skills of being a successful employee as a quality engineering. SKILLS & ABILITIES

Languages: Fluent in English and German, some proficiency in Spanish (4 years) Computer: Microsoft Office, SPSS statistical software, MATLAB programming technique, MathCad (3.1), SolidWorks, TecPlot, Mimics software ISO 13485, 21 CFR, Medical Devices, Biomedical Engineering, U.S. Food and Drug Administration (FDA), Manufacturing, PMA, 510(k) submissions Extensive lab experience, proven ability to learn fast and achieve results in high- pressure environment. Comfortable working in a fast-paced and changing environment. Highly attentive to detail.

Managing a wide range of projects from evaluation through conception and completion

Proven track record of working for tight deadlines and multitasking Can effectively work with a team, individually, or as a leader EXPERIENCE

9/1/2017-Current Quality Systems Engineer Intern, Fusion Orthopedics

Organized Company’s entire DHF for multiple systems. Completed all ECO’s for revisions dating back to 2015, along with several SOP’s and work instructions. Completed UDI labelling and entry into Global UDI Database for over 600 products. Oversaw and completed all incoming product LOT inspections. Helped create and submit 510(k) submissions to FDA. Participated in all design review meetings and took minutes for each meeting. 8/20/2015-

1/10/2016

Student Tutor, America Reads Program at Arizona State University

Tutored elementary children that attended title 1 schools in mathematics, reading, writing, and science. Created lesson plans to be approved by head coordinator several weeks in advance. Coordinated lesson plans in order to improve students’ weaknesses.

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EDUCATION

August 2014-

May 2018

Biomedical Engineering (BSE), Tempe, AZ, Arizona State University

Expected Graduation Date: 2018

Cumulative GPA 3.1/4.0

Awards: American University Scholarship

COMMUNICATION

Fusion Orthopedics

• Helped prepare company for audit to ensure that all documents were organized.

• Worked from oversees, regularly communicating with my boss to ensure tasks were completed punctually and successfully.

Arizona State University

• Regularly work in groups of three. Consistently take role of leader and delegate roles to be completed by fellow group members.

• Effective leader and gives feedback for improvement to ensure that all the completed work is at its full potential.

• Communicates regularly with professors and asks many questions for improvement.

Romanian Children’s Relief (2011-2014)

• Created organization that helped bring clothes, medical aid, and school supplies to orphanages in rural areas in Romania that were hugely affected by the fall of the communist regime. Travelled there two years in a row and was able to help volunteer with children with severe mental disabilities and children who were orphans.

Amnesty International (2012-2014)

• Worked within my school area to tackle the most pressing human rights violations. Would help get petitions signed and spread awareness. Caritas Austria (Summer 2016)

• Volunteered to help with refugees fleeing from Iran, Syria, and other war-torn countries. My tasks were to entertain children, help teach English, and get them acquainted with Vienna.

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LEADERSHIP

Capstone Project Team Leader:

• In charge of assigning tasks, making sure project follows specific deadlines, communicating with professional resources, helping other group members when needed to complete tasks on time.

BME 382 (Product Design):

• Oversaw the entire financial aspect of my projects. Including, making a cost analysis, market analysis, expected revenue, and a business plan. This was then presented in front of my entire graduated class. Project received a 98% overall.

BME 370 (Microcomputer Applications):

• Worked in a group of three to find a major medical device problem and create a solution. Created a voice automated surgical headlamp that functions via Bluetooth. My main job of the report was the data analysis and results section. Project received a 94%.

REFERENCES

Adam Cundiff, Fusion Orthopedics

CEO

Phone: 480-***-****

Mark Roberts, Fusion Orthopedics

Head of Operations

Phone: 480-***-****

Email: **@*****************.***

Email: ****@*****************.***

Vincent Pizziconi, Arizona State University

Biomedical Engineering Professor

Email: *******.*********@***.***

Contact this candidate