Yetnayet Shibre

**** **** ***, *******, **

Phone: 415-***-**** w Email: ac3cyy@r.postjobfree.com

Bioengineering

A top-performing bioengineer with a Bachelor of Science in Bioengineering and experience with biomedical equipment, compliant handling, product investigation and trending.

Key Skills

Wide knowledge of FDA regulations, safety standards and regulatory compliance guidelines.

Experience in complaint handling, reporting and trending.

Proficient with computer and Microsoft Office.

Excellent Written, Oral Communication and Interpersonal Skills.

Professional Experience

ZOLL, San Jose, CA September, 2015 – Current

Complaint Specialist

Developed and implemented a test technique for complaint investigation process to perform feasibility and reliability tests on returned products.

Lead or support teams with standard and non-standardization failure investigations of Catheters and other returned products.

Handles and processes potentially contaminated returned complaint products using appropriate PPE.

Analyzed, reviewed, and trends of complaint data monthly to identify new and systemic issues as necessary using spreadsheets, graphs and databases.

Prepare investigation documents and send an investigation summary report to the customer.

Serves as the contact for quality and regulatory related matters once determined there is a quality issue with the product.

Work with the Field Service Organization and various manufacturing facilities to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements both domestic and international.

Takes lead on specific complaint issues and coordinates with other departments to further investigate.

Interface with internal and external groups on post market quality-related issues.

Determines MDR and Vigilance reportability based on an understanding of the risks associated with product malfunction.

Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction.

Communicates with customers to establish a full understanding of the issues.

Manage and document thorough and accurate complaint records in the complaint handling system while ensuring they are processed in a uniform and timely manner.

Provides guidance and training to support staff and new analysts. May provide supervision/performance feedback of group to Management.

St. Jude medical, Sunnyvale, CA January, 2015 – September, 2015

post market surveillance coordinator

Enter complaints into compliant handling database.

Perform the preliminary classification of complaints and escalate complaints that require additional review.

Participate in process improvement activities to continuously improve process effectiveness

Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements )

Understands and can apply requirements of 21 CFR 820.198 – Complaint Handling

Understanding of 21 CFR 822 – Post Market Surveillance

Experience in FDA Medical Device Reporting (MDR)

Experience in Medical Device Vigilance Reporting (MDV)

Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP).

Attend and conduct training as required

Approve final complaint file for closure after all applicable actions are completed.

Interacts daily with customers via telephone and written correspondence regarding post market issues.

University of California, Riverside, CA October, 2013 – August, 2014

Volunteer Research Assistant, Dr. huinan liu lab

Used several types of staining media to investigate how mammalian cells interact with biodegradable polymers such as poly lactic acid (PLA) and poly lactic –co-glycerol acid (PLGA).

Performed PH measurements and titration to find acidity of biodegradable polymers.

Project Leader/Senior Design, Riverside, CA September, 2013 – July, 2014

Design and Build Medical Devices

Utilized Solidworks software, 3D printer and EEG headset to design prosthetic limbs.

Created a business plan and applied patent laws to the plan.

Performed data analysis and provided recommendations to achieve less costly medical devices.

Education & Certification

Bachelor of Science, Bioengineering, University of California, Riverside, CA

Graduated in 2014

Organizations

Society of Women Engineers, UC Riverside

Biomedical Engineering Society, UC Riverside

Contact this candidate