Quality Assurance Management

ALICIA SUSAN VARUGHESE Email:

*****@******.*** [pic]

**** ********* ***, *** * Philadelphia PA-15217

(M): 267-***-****

[pic]

OBJECTIVE

Seeking a full-time opportunity in the field of Regulatory Affairs and

Quality Assurance in the healthcare industry.[pic]

EDUCATION

Drexel University Philadelphia, PA Anticipated

Graduation - June 2013

Masters of Science in Biomedical Engineering

Present GPA-3.5/4.0

University of Calicut Kerala, India

September 2006 - June 2010

Bachelor of Technology in Biomedical Engineering

Equivalent GPA-3.6/4.0[pic]

RELEVANT COURSEWORK

Biomaterials Pharmacogenomics Engineering

Management

Project Management Medical Device Development Biomedical Ethics and

Law

Medical Sciences Medical Instrumentation Hospital

Engineering and Management

[pic]

RESEARCH

Graduate Research Drexel University

February 2012-May 2012

. TITLE : Application of large sized ZnSe Quantum Dots (QD's) in cosmetic

applications

. ADVISORS: Dr. Wan Shih, Dr. Wei-Heng Shih, Department of Material Science

Engineering Drexel University.

[pic]

WORK EXPERIENCE

RA/QA Associate (Intern) Cernostics Inc. Pittsburgh, PA

October 2012- March 2013

Cernostics TissueCipher (LDT) test for detection of risk-level of cancer

. Developed Regulatory plan for Cernostics AP lab according to CLIA/CAP

and OSHA standards.

. Established efficient Quality Management and Safety Management Plans

for Cernostics.

. Collate and maintained required files and documents to support

regulatory submissions for CLIA and CAP standards.

. Review, approve and author to Quality Systems and Safety Standard

Operating Procedure documents to ensure compliance with CLIA/CAP and

OSHA standards.

. Certified trainer for Cernostics and trained Cernostics team on

Quality and Safety Systems Training.

. Performed Validation testing on imaging software and image analysis

for the TissueCipher test.

. Executed Quality Assurance testing of the patient cohort tissue

samples.

. Established a Cernostics Equipment Manual based on the designed

Quality Management System.

Student Intern Office of Technology Commercialization Drexel University

June 2012- Sept 2012

. Assisted in launching technologies of Drexel University into the

healthcare market.

. Prepared executive reports for licensing the inventions to corporate

partners.

Teaching Assistant Department of Physics Drexel University

March 2012-June 2012

. Conducted recitation/discussion sessions and labs for a group of 20

students.

. Developed and Graded homework assignments and lab reports.

Graduate Engineer Trainee Gulf Drug Est., MOH, U.A.E.

May2011- July 2011

. Gained knowledge in biomedical maintenance management system and

protocols for hospital management in the Department of Biomedical

Engineering

. Assisted engineers with the maintenance and repair of equipment of NICU,

ICU and Hematology Labs.

[pic]

ACADEMIC PROJECTS

. Project Assessment on Portable device for Breast Cancer Screening

510 (k) report Coulter Project Drexel University

Apr 2012-June2012

. Implantable Stagnation Modifier for Cardiac Valves

Market Assessment Coulter Project Drexel University

Jan 2012-March 2012

. Haptic Feedback in MIS systems University of Calicut, India

(Project Leader) Aug 2009-

May 2010

[pic]

SPECIALITIES

. Skills : Regulatory-Clinical Anatomic Pathology documentation, Quality

Assurance, Quality Management system and standards, CLIA, CAP, OSHA, Test

validation, Regulatory Submissions

. Knowledge: FDA, 510(k), 21 CFR 820, ISO 13485, PMA, GLP, Risk Assessment,

FMEA analysis, CAPA, IND.

[pic]

ACADEMIC HONORS

. Recipient of the Dean's Fellowship for MS in Biomedical Engineering,

Drexel University

. Rank Holder for B.tech in Biomedical Engineering at University of

Calicut, India

[pic]

SOFTWARE PROFICIENCY

. Programming: C, MATLAB,HTML

. Assembly level : ATMEL 8051, 8085/8086

. Operating Systems: Win XP, Win Vista, Win7, MS Office

. Sharecloud : Atlassian Confluence

[pic]

Contact this candidate