Somesh Lalithraj

Senior Vice President, Quality, Regulatory & Clinical Affairs (Qrc) @Danaher

Sunnyvale, CA, US

EMAILS

s••••••••@stcloudstate.edu

MOBILE NUMBERS

+16•••••••32

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WORK HISTORY

Jun 2017 — Present

Senior Vice President, Quality, Regulatory & Clinical Affairs (Qrc) @Danaher

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San Francisco, CA, US

Lead the Global Quality, Regulatory & Clinical Affairs (QRC) team at Cepheid, Danaher Dx Platform.

EDUCATION

N/A

University of Minnesota

MS, Electrical Engineering

N/A

UMN Carlson School of Management

Master of Business Administration (M.B.A.)

SKILLS

FmeaQuality ManagementDesign of ExperimentsManufacturingQuality SystemResearch and Development (R&D)FdaCross-Functional Team LeadershipBiomedical EngineeringDesign ControlQuality AssuranceFailure Mode and Effects Analysis (Fmea)Process ImprovementTestingCorrective and Preventive Action (Capa)Medical DevicesCapaIso 13485

ABOUT SOMESH LALITHRAJ

MBA–level leader with over 20+ years of successful experience in the regulated healthcare industry* International experience including expat stints; multi-site supervision* Master Black Belt: Transactional Process Improvement, LEAN methodologies* Expertise in ISO 9001/13485/14969/14971, 21 CFR Part 820/803/806, MDR/IVDR* 483 and Warning Letter Remediation: Successful interactions with Domestic (FDA) and International (MHRA, PMDA, BfArM, CFDA, BSI, NSAI etc.) regulatory agencies/bodies* CAPA: Train, Mentor & Coach for exceptional problem-solving and implementation

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