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RESUME



Sandip N Kulkarni
Address: A1-101, Ankur Residency, Near Cipla Foundation, Warje, Pune-411058

Phone : 09881946595

E-mail: mail2sandipk@gmail.com/director@globaltechnologycentre.com




Education
MBA (MM)
BE( Mechanical)


Professional
Certified Lead Auditor ISO 9001-2008
Certified Lead Auditor ISO 13485-2003
Certified Lead Auditor CE Marking for Medical devices
Faculty for ISO 13485-2003

Technical
Undergone training on IEC 60601 series ( General, Collateral and Particular standards)
Undergone training on EMI/EMC
Undergone training on ISO 10993 series for Biocompatibility
Undergone training on standards related to clean room maintenance and validation
Undergone training on standards related to sterilization
Underergone training on ISO 17025 and ISO 15189 for Laboratory Management

Work Experience:

5 years working experience in Orthopedic Implant manufacturing including surgical instruments
and Medical Electronic equipments for Orthopedic surgery
2 Years working experience with Urology, Gastroenterology, infertility disposables and related
Medical equipment manufacturing
3 years working experience with material handling equipments manufacturers
7 years experience as
a Lead auditor with different European Notified Bodies and Indian Certification bodies as a
freelancer auditor ( approx 600 man-day auditing experience)
Consultant for ISO 13485- 2003 and CE Marking for Medical Device manufacturers
Faculty for ISO 13485-2003
Technical Director for Laboratories for IEC compliance, Biocompatibility and Aging study
( Accelerated/Real Time)
Annexure to Resume

A. Working Experience:
                                                                                        Position
                                                                                                        Length of
                                                                                   (Title/Function)
                         Service Area                               Company                              time in
                                                                                                         position

IEC compliance Testing , compliance to EC directives for
                                                                  Astute labs      Technical          April 2012-
general safety, EMI / EMC, Biocompatibility Testing and
                                                                  Pvt Ltd, Pune    Director           till Date
Accelerated aging study/ Efficacy study

                                                                  Safetek                             January
IEC compliance Testing , compliance to EC directives for                           Technical
                                                                  Laboratory,                         2011 – April
general safety, EMI / EMC                                                          Director
                                                                  Pune                                2012

IEC compliance, compliance to EC directives for general
safety, EMI / EMC and technical guidance on establishment
of the process and validation of the processes of different
machine manufacturers, different medical device
manufacturers, different pressure equipment manufacturers
and general electrical equipments,

coordination in pre-compliance and full compliance testing.

Consultancy to disposable medical device manufacturers
made up of different polymers like polyurethane,
                                                                  Global
polypropylene, polyethylene , ABS, PVC by plastic injection                                           June 2009
                                                                  technology       Director
moulding and plastic extrusion.                                                                       till date
                                                                  Centre
Consultancy to the manufacturers of different electrical and
electronic medical devices and general purpose machines
with processes including casting, forging, machining with
the help of CNC, VMC, Lathe and milling machine, sheet
metal work, powder coating, electrical assembly and wiring.

Consultancy to heavy fabrication works, water treatment
solutions.



                                                                  Zenith Quality
Management system certification and product certification                          Head- Product      May 2008 to
                                                                  Assessors Pvt
and third-party inspection services                                                Certification      June 2009
                                                                  Ltd

                                                                  BMQR
                                                                  Certifications
                                                                  Pvt Ltd,
                                                                                   Panel Auditor/     August 2007
Management system certification and                               SWISO India
                                                                                   Lead auditor       to May 2008
                                                                  Pvt Ltd



                                                                                                      September
product certification of medical device directive, machine        Moody ICL
                                                                                                      2005 to
directive, low voltage directive, electromagnetic compatibility   Certifications   CE auditor for
                                                                                                      September
directive, pressure equipment directive, personal protective      Ltd              a product
                                                                                                      2006
equipments directive, management system certification of                           certification
medical devices

Manufacturing, design and development and quality
                                                                  Nasan            Design
assurance of electro medical devices (at it embedded,
                                                                  Medicals         manager&
measuring instruments for different human body parameters                                             June 2005 to
                                                                                   Management
for diagnosis and monitoring), body parameters monitoring                                             September
                                                                                   Representative
equipment s                                                                                           2005
Manufacturing, design and development and quality
   assurance of polymer disposable medical devices made up of      R&D TECH                           April 2005 to
   plastic moulding and extrusion and manufacture of medical       INC              In charge of QA   June 2005
   electronic equipments include sheet metal work, fabrication,                     dept. and MR
   electrical wiring and assembly. Special process: wave
   soldering

   Manufacturing, design and development and quality               S.H.Pitkar
   assurance of implants made up of stainless steel machining      Orthotools
                                                                                    In charge of QA   June 2000 to
   on CNC and VMC, stainless steel casting including               Pvt. Ltd.
                                                                                    dept. and MR      April 2005
   investment casting, forging, design and maintenance of tools
   Jigs and fixtures

                                                                                    Process
                                                                                    development
                                                                   Autotech
   Process designed and quality assurance of MS and SS                              engineer          10 September
                                                                   Industries
   fabricated structures, heavy fabrication work, installation                      (combined         1999 to 10
   and commissioning.                                                               activity of       June 2000
                                                                                    production and
                                                                                    QA dept).

                                                                                    Production        19th
                                                                   Intelligent
   Production of overhead conveyor systems, industrial ovens,                       Engineer,         September
                                                                   conveyors and
   vertical causal systems ( sheet metal fabrication/structural                     member on         1997 to 10
                                                                   stackers pvt
   fabrication, assembly installation and commissioning)                            development       September
                                                                   Ltd.
                                                                                    committee         1999



   B. Training details:


Dates of         Location of                Training program details
training         turning
programs         conducted

25.01.2007       Moody ICL             ISO 9001:2000 QMS - Internal / External Auditing Techniques : Lead
                 Certifications        Auditors Course - ISO 9001:2000 Quality Management System
                 Ltd

21.07.2005       Moody ICL             BS 7799 ISMS Information security requirements ( ISO 27001) : BS 7799
                 Certifications        ISMS -CIS Information security Manager ( ISO 27001)
                 Ltd

7th to 9th       ITC Zlin Czech        Principles and procedures according to ISO 17021
October 2008     Republic              Quality manual, procedures and form of CB No. 3002
                                       Quality manual, procedures and form of CB No 3020
                                       Documentation of QMS in production of Medical Devices



7th to 9th       ITC Zlin Czech        MDD and AIMD conformity assessment
October 2008     Republic              Conformity assessment according to IVD Directive
                                       Documentation of QMS in production of Medical Devices
                                       Recertification of OEM-OBL in Medical Devices
                                       Scope of ITC Notification and Accreditation
                                       Assigning of the New Approach Directives to products
                                       Conditions for using foreign laboratories

                                       Condition for including of external auditors into NB auditors team
                                       Guidance for classification of Medical Devices

Third and        Centre for            Course on Laboratory Competence as per ISO/IEC 17025: 2005 & Aspects of
fourth of May    electronic test       Internal Audit
2008             engineering
                 Pune
21-22 Feb       Centre for        Training course on Medical Laboratory Competence as per ISO 15189:2003 &
2008            electronic test   Aspects of Internal Audit
                engineering
                Pune

13th and 14th   ITC Zlin Czech    Get acquainted with results of MSCB-3002 activity and economic framework
may 2009        Republic          of cooperation
                                  Quality Manual of MSCB-3002

                                   experience with implementation of ISO 17021 requirements at MSCB activity
                                  results of accreditation process according to ISO 17021

                                   procedure of system certification

                                  competence of auditor and technical expert in branches and management
                                  system

                                  submitting)

                                  list of approved auditors and technical experts

                                  evaluation of auditors and technical experts

                                  audit forms and their implementation and certification proceeding

                                  most frequent faults and mistake in filling the forms

                                  approach to specialized selection for auditor or website section 4 auditors

                                  running on different documents of certification body

                                  strategy of certification body for transition period of standard 9001 2008
                                  implementation

                                  meeting the standards requirements

                                  risk management of medical devices

                                  legal requirements related to environmental management system and
                                  occupational health and safety

26 October to   CERMET Italy,     EC Mark 93/42/EEC and 2007/47/EC Medical Devices Directives and IS0
5 November                        13485 requirements in auditing certification processes
2009

23.05.2008      National          Technical running on understanding the requirement of IEC 60601,IEC
                electrical and    60204, IEC 60950, IEC 61010, IEC 60335, identification of the requirements
                electronic        from particular standards
                laboratory
                (West)

Third and       Centre for bio-   Energy field training course for energy field imaging assessment and research
fourth of       field sciences
January 2009

Sixth of        National          testing methods of bio compatibility of medical devices as per ISO 10993
February 2009   toxicology
                Centre

9 September     Quality service   Assessment of the management system as per ISO 9001, assessment of
2011            Switzerland       management system as per ISO 13485, assessment of the management
                                  system as per occupational health and safety requirements, assessment of
                                  the management system as per ISO 13980 requirements

18 January      3 EC              Medical device directive and CE marking approach
2011            international
                Slovakia

18th            3 EC              Auditor training course as per ISO 17021
September       international
2009            Slovakia

18 January      3 EC             Written examination training course of ISO 9001 2008 and ISO 13485 2003
2011            international    and medical device directives
                Slovakia

14 September    3 EC             Written examination training course of new requirements of ISO 17021 2011
2011            international
                Slovakia

12 August       MEYER,           CE marking and new approach directives, operational procedures and
2010            Turkey           documents of conformity assessment of the notified body, CE marking scope
                                 of the notified body

Sixth to 8      National         Specifications for testing and monitoring to prove continued compliance
February 2011   electrical and   with ISO14644-1, airborne article count Class as per IS014644-1, Air-borne
                electronic       particle and micro biological Classification According to EU GMP & Optional
                laboratory       tests as per IS014644-3
                (West)


9th to 12th     National         Training program on process establishment according to IS011135-1:2007
February 2011   electrical and   Sterilization of health care products –Ethylene Oxide Part 1 and EN 550
                electronic
                laboratory
                (West)

12 to 15th      National         Training program on particular requirements for safety of infusion pumps
February 2011   electrical and   and controllers, training program on particular requirements for safety of
                electronic       diagnostic and therapeutic laser equipments, training program on particular
                laboratory       requirements for safety of ultrasonic medical diagnostic and monitoring
                (West)           equipments




   C. Certificate Copies
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni
Resume Of Sandip N Kulkarni

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Resume Of Sandip N Kulkarni

  • 1. RESUME Sandip N Kulkarni Address: A1-101, Ankur Residency, Near Cipla Foundation, Warje, Pune-411058 Phone : 09881946595 E-mail: mail2sandipk@gmail.com/director@globaltechnologycentre.com Education MBA (MM) BE( Mechanical) Professional Certified Lead Auditor ISO 9001-2008 Certified Lead Auditor ISO 13485-2003 Certified Lead Auditor CE Marking for Medical devices Faculty for ISO 13485-2003 Technical Undergone training on IEC 60601 series ( General, Collateral and Particular standards) Undergone training on EMI/EMC Undergone training on ISO 10993 series for Biocompatibility Undergone training on standards related to clean room maintenance and validation Undergone training on standards related to sterilization Underergone training on ISO 17025 and ISO 15189 for Laboratory Management Work Experience: 5 years working experience in Orthopedic Implant manufacturing including surgical instruments and Medical Electronic equipments for Orthopedic surgery 2 Years working experience with Urology, Gastroenterology, infertility disposables and related Medical equipment manufacturing 3 years working experience with material handling equipments manufacturers 7 years experience as a Lead auditor with different European Notified Bodies and Indian Certification bodies as a freelancer auditor ( approx 600 man-day auditing experience) Consultant for ISO 13485- 2003 and CE Marking for Medical Device manufacturers Faculty for ISO 13485-2003 Technical Director for Laboratories for IEC compliance, Biocompatibility and Aging study ( Accelerated/Real Time)
  • 2. Annexure to Resume A. Working Experience: Position Length of (Title/Function) Service Area Company time in position IEC compliance Testing , compliance to EC directives for Astute labs Technical April 2012- general safety, EMI / EMC, Biocompatibility Testing and Pvt Ltd, Pune Director till Date Accelerated aging study/ Efficacy study Safetek January IEC compliance Testing , compliance to EC directives for Technical Laboratory, 2011 – April general safety, EMI / EMC Director Pune 2012 IEC compliance, compliance to EC directives for general safety, EMI / EMC and technical guidance on establishment of the process and validation of the processes of different machine manufacturers, different medical device manufacturers, different pressure equipment manufacturers and general electrical equipments, coordination in pre-compliance and full compliance testing. Consultancy to disposable medical device manufacturers made up of different polymers like polyurethane, Global polypropylene, polyethylene , ABS, PVC by plastic injection June 2009 technology Director moulding and plastic extrusion. till date Centre Consultancy to the manufacturers of different electrical and electronic medical devices and general purpose machines with processes including casting, forging, machining with the help of CNC, VMC, Lathe and milling machine, sheet metal work, powder coating, electrical assembly and wiring. Consultancy to heavy fabrication works, water treatment solutions. Zenith Quality Management system certification and product certification Head- Product May 2008 to Assessors Pvt and third-party inspection services Certification June 2009 Ltd BMQR Certifications Pvt Ltd, Panel Auditor/ August 2007 Management system certification and SWISO India Lead auditor to May 2008 Pvt Ltd September product certification of medical device directive, machine Moody ICL 2005 to directive, low voltage directive, electromagnetic compatibility Certifications CE auditor for September directive, pressure equipment directive, personal protective Ltd a product 2006 equipments directive, management system certification of certification medical devices Manufacturing, design and development and quality Nasan Design assurance of electro medical devices (at it embedded, Medicals manager& measuring instruments for different human body parameters June 2005 to Management for diagnosis and monitoring), body parameters monitoring September Representative equipment s 2005
  • 3. Manufacturing, design and development and quality assurance of polymer disposable medical devices made up of R&D TECH April 2005 to plastic moulding and extrusion and manufacture of medical INC In charge of QA June 2005 electronic equipments include sheet metal work, fabrication, dept. and MR electrical wiring and assembly. Special process: wave soldering Manufacturing, design and development and quality S.H.Pitkar assurance of implants made up of stainless steel machining Orthotools In charge of QA June 2000 to on CNC and VMC, stainless steel casting including Pvt. Ltd. dept. and MR April 2005 investment casting, forging, design and maintenance of tools Jigs and fixtures Process development Autotech Process designed and quality assurance of MS and SS engineer 10 September Industries fabricated structures, heavy fabrication work, installation (combined 1999 to 10 and commissioning. activity of June 2000 production and QA dept). Production 19th Intelligent Production of overhead conveyor systems, industrial ovens, Engineer, September conveyors and vertical causal systems ( sheet metal fabrication/structural member on 1997 to 10 stackers pvt fabrication, assembly installation and commissioning) development September Ltd. committee 1999 B. Training details: Dates of Location of Training program details training turning programs conducted 25.01.2007 Moody ICL ISO 9001:2000 QMS - Internal / External Auditing Techniques : Lead Certifications Auditors Course - ISO 9001:2000 Quality Management System Ltd 21.07.2005 Moody ICL BS 7799 ISMS Information security requirements ( ISO 27001) : BS 7799 Certifications ISMS -CIS Information security Manager ( ISO 27001) Ltd 7th to 9th ITC Zlin Czech Principles and procedures according to ISO 17021 October 2008 Republic Quality manual, procedures and form of CB No. 3002 Quality manual, procedures and form of CB No 3020 Documentation of QMS in production of Medical Devices 7th to 9th ITC Zlin Czech MDD and AIMD conformity assessment October 2008 Republic Conformity assessment according to IVD Directive Documentation of QMS in production of Medical Devices Recertification of OEM-OBL in Medical Devices Scope of ITC Notification and Accreditation Assigning of the New Approach Directives to products Conditions for using foreign laboratories Condition for including of external auditors into NB auditors team Guidance for classification of Medical Devices Third and Centre for Course on Laboratory Competence as per ISO/IEC 17025: 2005 & Aspects of fourth of May electronic test Internal Audit 2008 engineering Pune
  • 4. 21-22 Feb Centre for Training course on Medical Laboratory Competence as per ISO 15189:2003 & 2008 electronic test Aspects of Internal Audit engineering Pune 13th and 14th ITC Zlin Czech Get acquainted with results of MSCB-3002 activity and economic framework may 2009 Republic of cooperation Quality Manual of MSCB-3002 experience with implementation of ISO 17021 requirements at MSCB activity results of accreditation process according to ISO 17021 procedure of system certification competence of auditor and technical expert in branches and management system submitting) list of approved auditors and technical experts evaluation of auditors and technical experts audit forms and their implementation and certification proceeding most frequent faults and mistake in filling the forms approach to specialized selection for auditor or website section 4 auditors running on different documents of certification body strategy of certification body for transition period of standard 9001 2008 implementation meeting the standards requirements risk management of medical devices legal requirements related to environmental management system and occupational health and safety 26 October to CERMET Italy, EC Mark 93/42/EEC and 2007/47/EC Medical Devices Directives and IS0 5 November 13485 requirements in auditing certification processes 2009 23.05.2008 National Technical running on understanding the requirement of IEC 60601,IEC electrical and 60204, IEC 60950, IEC 61010, IEC 60335, identification of the requirements electronic from particular standards laboratory (West) Third and Centre for bio- Energy field training course for energy field imaging assessment and research fourth of field sciences January 2009 Sixth of National testing methods of bio compatibility of medical devices as per ISO 10993 February 2009 toxicology Centre 9 September Quality service Assessment of the management system as per ISO 9001, assessment of 2011 Switzerland management system as per ISO 13485, assessment of the management system as per occupational health and safety requirements, assessment of the management system as per ISO 13980 requirements 18 January 3 EC Medical device directive and CE marking approach 2011 international Slovakia 18th 3 EC Auditor training course as per ISO 17021
  • 5. September international 2009 Slovakia 18 January 3 EC Written examination training course of ISO 9001 2008 and ISO 13485 2003 2011 international and medical device directives Slovakia 14 September 3 EC Written examination training course of new requirements of ISO 17021 2011 2011 international Slovakia 12 August MEYER, CE marking and new approach directives, operational procedures and 2010 Turkey documents of conformity assessment of the notified body, CE marking scope of the notified body Sixth to 8 National Specifications for testing and monitoring to prove continued compliance February 2011 electrical and with ISO14644-1, airborne article count Class as per IS014644-1, Air-borne electronic particle and micro biological Classification According to EU GMP & Optional laboratory tests as per IS014644-3 (West) 9th to 12th National Training program on process establishment according to IS011135-1:2007 February 2011 electrical and Sterilization of health care products –Ethylene Oxide Part 1 and EN 550 electronic laboratory (West) 12 to 15th National Training program on particular requirements for safety of infusion pumps February 2011 electrical and and controllers, training program on particular requirements for safety of electronic diagnostic and therapeutic laser equipments, training program on particular laboratory requirements for safety of ultrasonic medical diagnostic and monitoring (West) equipments C. Certificate Copies