Customer Service Medical Device
Resume:
RAGINI DEORE
Houston,TX
************@*****.***
SUMMARY
Highly motivated graduate biomedical engineer with knowledge of Quality system regulations for class I, II and III
medical devices. Experience working with medical professionals and maintained hospital instruments. Assisted in the
product verification and software validation processes. Knowledge about risk management tools and complaint handling
procedure. Worked on documentation including Engineering Change Orders (ECO) and Medical device reporting
(MDR). Experience with Corrective and Preventive Action (CAPA) procedures.
Standards and Regulations: ISO 9001, ISO 13845, Quality Systems Regulations (QSR) for medical device/ combination
device – FDA Title 21 CFR 820, CFR 803,CFR 211,ISO 14971-Risk Management (FMEA)
Key Skills: Outstanding problem-solving, and quick learning ability, Superior communication, customer service, both
independent and team worker, as required, MS Office proficiency and tracking-software familiarity, Ability to multi-task
and prioritize effectively, Poised and patient when dealing with clients.
WORK EXPERIENCE
Graduate Research Assistant
University of Toledo, Ohio August 2009 - May 2012
• Proficiently worked in the bioengineering department to assist students for performing biostatistician analysis
using Microsoft excel testing tools
• Successfully applied bio-physics properties to develop medical application from biomaterial using various design
tools.
Biomedical Quality Intern
Wockhardt Hospital, Nasik December 2008-July 2009
• Assisted in documentation and reviewing Quality system regulations along with Risk management in agreement
with the standard operating procedures( SOP)
• Discussed complaint handling and device reporting issues with medical professional and staff
• Maintained installing and servicing reports for ICU/ Surgical equipments and interacted with other departments
on ISO 13845 quality standards
R &D Engineer
Research and development department, Transasia biomedical Pvt.Ltd. June 2007-
June 2008
• Efficiently worked in a team of software and hardware engineers to develop fully automated pathological
analyzer
• Involved in product development from planning till execution phase and conducted quality control,
performance testing on newly developed product
• Performed risk analysis and assisted in developing software validation procedures, bug tracking and
fixing
• Successfully installed new feature in existing product and performed CAPA investigation for customer
satisfaction
• Effectively performed quality and validation tests to evaluate the product and maintained GMP
compliance with reviewing Engineering Change Orders (ECO’s) and created documents according to ISO13485
• Efficiently used statistical tool for data analysis, involved in product design planning and developed
regulatory strategies.
EDUCATION
Masters of Science in Biomedical Engineering, University of Toledo, Ohio, August 2012
Bachelors in Biomedical Engineering, Mumbai University, India, July 2007
TECHNICAL SKILLS
• Programming/Assembly Languages: C, C++, MATLAB, C251, C51, ST10, VHDL, Linux
• Application Packages: Microsoft Office (Words, Excel, Access, PowerPoint, Project),SQL database,Mercury
QC,QTP. Minitab, SPC
COURSE WORK
Biomedical instruments, Medical Imaging, Physiology, Biomedical quality control, Micro controllers, Electronic circuits
and designing, Advanced Biomechanics, Orthopedic biomechanics.
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