Quality Assurance Medical

S U N I T H A A N N G E O R G E

***** ******* *******, *** *** San Diego CA 92128 213-***-****

*************@*****.*** http://www.linkedin.com/in/sunithaanngeorge

PROFILE

A result-oriented and passionate Biomedical engineer with prior experience in Medical devices industry

Previous Quality Assurance & Research internship experience with medical device. Graduate coursework on 510(k), PMA, IDE submissions, ISO 14971 (Risk Analysis & Management)

Working knowledge of FDA-QSR (21 CFR 820), ISO 13485, 5S, Kaizen, SPC & SQC, FMEA, CAPA management, Complaint handling, Supplier approval.

Well knowledgeable about the engineering aspects of a medical device.

WORK EXPERIENCE: QUALITY (MEDICAL DEVICES)

Scion Medical Technologies, Newton, MA-02464 April 2nd 2012 to current

Quality Assurance Specialist

Key functions:

Review and release SOPs and forms

Release FDA-QSR and ISO 13485 compliant Quality Manual

Document Control Management

Compile the Device Master Record for all devices

Receive finished goods and verify documents to assure conformance

Assist Operations in approving suppliers

BPL Healthcare, INDIA June 5th 2008 to February 25th 2009

Asst. Manager, Quality Assurance department

Teamed with Production, R&D, Regulatory to obtain the first regulatory approval for single channel ECG machine which increased the company’s market in government sectors and hospitals.

Successfully conducted Internal Audits for ISO 13485:2003, and assisted management during external audits, auditing suppliers/contract manufacturers.

Identified and encouraged continuous improvement with the objective of achieving quality, reliability and cost improvements via Kaizen implementation at shop-floor.

Ensured that the products consistently met and exceeded customer requirements and specifications through rigorous validation and verification process of new prototypes, equipments.

Teamed with production engineers in projects involving circuit level troubleshooting of Defibrillators, ECG recorders, patient monitors.

Solved complaints and handled CAPA development and completion using root cause analysis, cause and effect analysis and other SPC-SQC techniques and methods.

Conducted verification and validation for Pulse oximeter and Central Nursing station modules.

Additional job responsibilities have included:- Document and Records Management, Complaints Management, Change Control, Non-Conformances Management, Supervision of Incoming and Outgoing Quality control, Validation of products, Product Release, Review of DHR and DHF, Supervision of in-house and external agency calibration of test equipments.

WORK EXPERIENCE: ENGINEERING (MEDICAL IMAGING)

Doheny Retina Institute, Los Angeles, CA 90033 Sept 6th to Dec 14th 2011, Feb 14th to March 15th 2012

Medical Imaging Software Development intern

Assist in development of an algorithm to automatically segment retinal layers in 2D Spectral Domain Optical Coherence Tomography Images as part of the project “Automatic detection of retinal disease conditions”; Assist reading center in obtaining and interpreting results and parameters of segmented retina from Matlab code.

Second Sight Medical Products, Inc., Sylmar, CA 91342 May 23rd to Aug 5th 2011

R&D intern

Developed methods to assist in assessing the “Fit of the Array for ArgusTM II Retinal Prosthesis System". The ArgusTM II System is intended to provide electrical stimulation of the retina to elicit visual perception in blind people with outer retinal degeneration, such as retinitis pigmentosa.

EDUCATION

Master’s of Science, Biomedical Engineering GPA 3.593/4

University of Southern California, Los Angeles, US Dec 2011

Relevant Coursework: Biomedical Systems (Respiratory & Cardiac); Quality systems and standards; Medical products regulation, Signals and Systems, Advance medical Imaging & Imaging informatics, Ultrasound Imaging, Digital Image processing

Bachelor of Technology, Biomedical Engineering GPA 3.8/4

Sathyabama University, Chennai, India April 2008

Relevant Coursework: Analytical, Diagnostic & Therapeutic Instrumentation; Electronic Devices and Circuits; Microcontrollers; Biotransducers and Biosensors; Human Anatomy and Physiology; Biomechanics; Biomaterials; Artificial Organs, Prosthetic Devices & Orthotic Devices

ACADEMIC PROJECTS (2010-2011)

Quality and Regulatory projects (Medical devices):

Completed documentation/formulation of a 510(k) application for a Class II (Tympanostomy tube) mock device

Mock Internal Auditing and recording observations/NCs of the Quality Assurance department of a medical device company

Creating mock SOP for the Quality Assurance department of a popcorn manufacturing company

Engineering projects:

2D parallel beam CT image reconstruction and filtering

Simulation of the effect of filtering on axial resolution in ultrasound imaging

Demonstrate aliasing and effect of missing k-space information on MRI images

Outlier removal from 3D geometrical retinal implant surface data using Knowledge based data discovery techniques (Density-based clustering for surfaces of varying sampling frequency).

Contact this candidate