Vikram Chandra

Baltimore, MD

Medical Devices

Philips
Vice President, Quality and Regulatory Head, Image Guided Therapy
Thermo Fisher Scientific 2016 - Oct 2018
Senior Director, Global Quality and Regulatory, Laboratory Products Division
Zimmer Biomet 2013 - 2015
Director Quality
Bd Jun 2006 - Jul 2013
Quality Management and Leader
Premier Election Solutions Jun 2004 - Jun 2006
Quality Assurance Manager

Medical Devices
Six Sigma
Quality Management
Quality System
Iso 13485
Fda
Quality Assurance
Manufacturing
Gmp
Process Improvement
Product Development
Quality Auditing
Team Leadership
Management
Design Control
Capa
Quality Control
Fda Gmp
Instrumentation
Regulatory Requirements
Reliability Engineering
Iso 14971
Ce Marking
Dmaic
Iso 9000
Root Cause Analysis
Supplier Quality
Testing
V&V
Validation
21 Cfr
Design of Experiments
Change Control
21 Cfr Part 11
Iso 9001

Baltimore, Maryland Area

Medical Devices

BD

Jun 2006 to 2000
Quality Leader
Diebold Election Systems
Annapolis, MD
Jun 2004 to Jun 2006
Quality Assurance Manager
Hughes Network Systems
Germantown, MD
Aug 1994 to Jan 2004
Quality Engineer/Team Lead
CALCE Electronic Packaging Research Center

Aug 1992 to Aug 1994
Research Assistant

The University of Maryland
College Park, MD
Aug 1992 to Aug 1994
M.S. in Mechanical Engineering

SKILLS PROFILE Class I, II and III Medical Device experience Direct FDA interactions; participated in multiple FDA audits and communication 21 CFR Part 820 and 11, IVD, JPAL, CMDR, ISO 9001, 14971 and 13485 Standards; cGMP Guidelines Coach, Manage and Lead Project/Product QA teams, programs & initiatives Design Control, Software Quality, Post Market Quality and Compliance, Reliability Engineering Leadership, Management skills; Professional Development, Creating alliances, loyalty and strong team spirit Implement Quality Programs from VOC, Design & Development, Manufacturing Operations and Launch phases CAPA management, Complaint Handling and Yield Improvements Statistical (SPC) Tools, FTA and FMEA experience, Hazard Analysis and Risk Management Supplier Management and partnerships, Site Transfers and Audit Programs Created Quality Vision, Strategy and launched multiple quality teams to support KBO's Reliability Modeling, Analysis and Prediction and testing to enhance product quality and reliability. Strong Communication Abilities, Effective Presentations including customer and vendor interactions. TECHNICAL SKILLS QA/Reliability Tools: Mentor Graphics, MSI Reliability Analysis Distributions, Statistical Process Control, Sampling Methodologies, MIL-STD-217, ANSI Standards Software: SAP, Java, Microsoft Office Suite. Operating Environments: Windows FDA QSR Guidelines (Part 11, Part 820); CMDR; ISO 13485, 9001 and 14971 Standards; JPAL and IVD directive

United States