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Subhashree Ravichandran

age ~37

from San Jose, CA

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Subhashree Ravichandran Phones & Addresses

  • San Jose, CA
  • Milpitas, CA
  • Fremont, CA
  • Tustin, CA
  • Los Angeles, CA

Work

  • Company:
    Childrens hospital los angeles
    Jun 2010
  • Position:
    Research assistant

Education

  • School / High School:
    University of Southern California- Los Angeles, CA
    May 2011
  • Specialities:
    M.S. in Biomedical Engineering

Skills

Medical Device Diagnostics: IDE • PMA • 510(k) • CE marking • QSRs • Post Marketing Surveillance Quality ... • ISO [] 19011). CAPA • Risk Analysis (FMEA • RCA). Audit checklists • SOP revisions • Work Instructions • Test reports. DMAIC Tools • Project Management tools. Documentation ... • 510(k). IND • CMC requirements • NDAs • ANDAs • Post-Marketing Surveillance studies • AE reporting • Compliance requirements for GMP • GLP • GCP. Medical Product Safety: Complai... • MedWatch & Vigilance reports. Crisi... • HACCP • ICH Q8 • Q9 • and Q10 • REMS • FDA Initiatives • FMEA • FTA

Resumes

Subhashree Ravichandran Photo 1

Product Engineer

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Location:
San Francisco, CA
Industry:
Medical Devices
Work:
Childrens Hospital Los Angeles since Jul 2010
Researcher
Indian Institute of Technology, Madras May 2008 - Aug 2008
Summer Fellowship
Education:
University of Southern California 2009 - 2011
M.S, Biomedical Engineering SRM University
Skills:
Medical Devices
Biomedical Engineering
Quality Assurance
Medical Imaging
Image Processing
Iso 13485
Design Control
Fda
Quality System
Capa
V&V
U.s. Food and Drug Administration
Cross Functional Team Leadership
Regulatory Affairs
Risk Management Tools
Gmp
Risk Management
Mdr
Capas
Microsoft Office
Udi
Teamwork
Certifications:
Iso13485:2003 Lead Auditor(Tpecs)
Anatomy of the Chest, Abdomen and Pelvis
Subhashree Ravichandran Photo 2

Subhashree Ravichandran

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Subhashree Ravichandran Photo 3

Subhashree Ravichandran Los Angeles, CA

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Work:
CHILDRENS HOSPITAL LOS ANGELES

Jun 2010 to 2000
RESEARCH ASSISTANT IMAGING LAB., INDIAN INSTITUTE OF TECHNOLOGY

Jun 2007 to Aug 2007 University of Southern California
Los Angeles, CA
May 2007 to May 2007
STUDENT WORKER (VITERBI EXTERNAL RELATIONS AND THE DEPT. OF FIRESAFETY) VIJAYA HOSPITAL
Chennai, Tamil Nadu
Jun 2006 to Aug 2006
INTERN
Education:
University of Southern California
Los Angeles, CA
May 2011
M.S. in Biomedical Engineering SRM University
May 2009
B.Tech. in Biomedical Engineering
Skills:
Medical Device Diagnostics: IDE, PMA, 510(k), CE marking, QSRs, Post Marketing Surveillance Quality Systems and Standards: (21 CFR [] 211, ISO [] 19011). CAPA, Risk Analysis (FMEA, RCA). Audit checklists, SOP revisions, Work Instructions, Test reports. DMAIC Tools, Project Management tools. Documentation Controls, 510(k). IND, CMC requirements, NDAs, ANDAs, Post-Marketing Surveillance studies, AE reporting, Compliance requirements for GMP, GLP, GCP. Medical Product Safety: Complaint Investigation and Reportability determination. MDR, MedWatch & Vigilance reports. Crisis management plans and recall procedures will be reviewed with a particular focus on the special challenges faced by medical product manufacturers. Risk Management: ISO 14971, HACCP, ICH Q8, Q9, and Q10, REMS,FDA Initiatives, FMEA, FTA
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