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Devendra Sharma

Devendra Sharma

ENGINEER-TQM

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  • Timeline

  • Skills

    Business process mapping
    Components
    Ms project
    Process control
    Kaizen
    Iso
    Quality system
    Iso 14001
    Occupational health
    Quality circle
    Iso 13485
    Tqm
    Minitab
    Quality assurance
    Six sigma
    Iso 9000
    Quality management
    Quality auditing
    Lean manufacturing
    Product quality
    Root cause analysis
    Quality control
    Capa
    Fmea
    Project management
    Spc
    Process improvement
    Manufacturing
    Supplier quality
    Continuous improvement
    Dmaic
    Process engineering
    Ts16949
    Value stream mapping
    Apqp
    Operational excellence
    Poka yoke
    Ppap
    Auditing
    Iso standards
    Total quality management

  • About me

    Six Sigma Black Belt certified, Corporate Quality Representative with substantial in-house Total Quality Management experience (Manufacturing and Service Sector) including: - Ensuring Product quality at Incoming / Inprocess / Outgoing stage and customer complaint handling -Hands on Service quaity initiatives -Implementation, Monitoring and Tutor of Various BPMS e.g.ISO 9001:2008, ISO 13485:2003, ISO 14001:2004, OHSAS 18001:2007, SA 8001:2008 etc. -Facilitation of Six sigma and Process improvement projects -Hands on experience of Various Business Excellence Awards e.g.Rajiv Gandhi National Quality Award, IMC Ram Krishna Bajaj National Quality Award, CII-Exim Bank Award, Golden Peacock National Quality Award etc. Specialties: -ISO (9001:2008, ISO 13485:2003, ISO 14001:2004, OHSAS 18001:2007, SA 8001:2008) -Six Sigma Projects execution and mentoring -Business Excellence (Quality,Environment , Health & Safety) initiatives roll-out -5'S' / KAIZEN / QUALITY Circle

  • Education

    • IMT GHAZIABAD

      2009 - 2012
      Master of Business Administration (MBA) OPERATIONS MANAGEMENT

    • Birla Institute of Technology and Science, Pilani

      -
      BS ENGINEERING AND TECHNOLOGY

  • Experience

    • MOSER BAER INDIA LIMITED

      Jul 2001 - Mar 2007
      ENGINEER-TQM

    • DELHI INTERNATIONAL AIRPORT PVT LTD

      Apr 2007 - Jun 2009
      EXECUTIVE-Total Quality Management

      DIAL is GMR group of companies engaged in Operation Maintenance and Development activities of IGI airport Delhi

    • BUREAU VERITAS CERTIFICATION INDIA PVT LTD

      Jul 2009 - Dec 2010
      Lead Auditor & Tutor - ISO 9001,ISO 14001 & SA8000

      Worked as Lead Auditor & Trainer - IMS (QMS,EMS & SA 8000). BVCI is formerly known as BVQI a well renowned certification body for ISO.

    • MUMBAI INTERNATIONAL AIRPORT PVT. LTD.

      Dec 2010 - Sept 2011
      [SIX SIGMA BLACK BELT] DY. MANAGER- QUALITY

      Facilitation and mentoring of improvement ProjectHandling MR Function for ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007 management System.OMDA initiative Handling and reporting to top ManagementHandling of Process Service Quality AuditsEnsuring proper Root Cause analysis and CAPA for non-compliances at all stage of processes or Services

    • STRYKER

      Sept 2011 - Feb 2013
      Associate Tech. Lead

      Leading ISO 13485:2003 standard project implementation and its integration with other Styrker entity.

    • Stryker Global Technology Centre

      Mar 2013 - Oct 2015
      Team Lead - Quality Assurance

      Responsible for implementation of Quality Management System for Stryker India Commercial (Supply Chain, Sales & Marketing and Servicing ) Division. Interacting with global and regional counterparts, implement global policies & standards.Responsible for Implementation of e-DHF for New Product Development Process.Responsible for managing the quality assurance program across Stryker India distribution channel.In this role, I interact with colleagues from customer service center, sales & marketing, supply chain, regulatory affairs to ensure compliance with all applicable regulatory requirements and company policies and procedures. Responsible for continually improving organizational performance in line with strategic quality goals, through implementation of the Quality Management System (Quality Manual, Quality Policies, SOPs), auditing and CAPA process.As a peoples’ manager, I am conversant with associated responsibilities such as staffing review, objectives setting, work assignment and performance management.Provide Quality oversight for the complaint management process including product Hold, Recall and Product Field Action.Responsible for Label release of products for regulatory compliance. Leading Six Sigma Initiative and Quality related training at organization level. Show less

    • India Medtronic Pvt. Ltd

      Oct 2015 - May 2019
      Head-Quality & EHS (Indian Subcontinent)

    • Adwith

      Jun 2019 - now
      Medical Device Consultant (USFDA|CE|India MDR|ISO 13485|Turnkey Project)

      Medical Device Consultant (USFDA|CE|India MDR|ISO 13485|Turnkey Project) :Our Organization is working for Strategic Development of clients in the Regulatory and Quality domain for the Medical Devices, Pharmaceuticals and Food industry.

  • Licenses & Certifications

    • LEAD AUDITOR ISO 9001:2008

      BSI INDIA
      Jul 2013

    • ISO 13485:2003 Lead Auditor Course

      BSI India
      Jan 2012

    • SA8001:2008 LA Course

      RINA- SAAS
      Aug 2010

    • ISO 10002:2004 Complaint Management Implementation Course

      BSI INDIA
      May 2008

    • Producing Zero Defect through Statistical Technique (MSA + SPC)

      CII
      Jan 2008

    • LEAD AUDITOR ISO 9001:2000

      BSI INDIA
      Oct 2007

    • ISO 10015 Training Management System

      NITS- BIS
      Feb 2007

    • OHSAS 18001:2007 IMPLEMENTATION TRAINING COURSE

      BSI INDIA
      Jul 2006

    • LEAD AUDITOR ISO 14001:2004

      BSI INDIA
      Jun 2006

    • Internal Auditor ISO 14001:2004

      QGS
      Mar 2006

  • Honors & Awards

    • Awarded to Devendra Sharma
      Great Manager Award - Annual STRYKER GLOBAL TECHNOLOGY CENTER Feb 2014
    • Awarded to Devendra Sharma
      Functional excellence Award-Annual Stryker Global Technology Centre Mar 2013 QMS (ISO 13485:2003 & ISO 9001:2008) certification and Integration of Quality Management System (SGTC + SIPL).