Resume Of Sandip N Kulkarni


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Resume for Consultant of ISO 9001-2008, ISO 13485-2003 Technical Consultant for IEC compliance and CE Marking

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Resume Of Sandip N Kulkarni

  1. 1. RESUMESandip N KulkarniAddress: A1-101, Ankur Residency, Near Cipla Foundation, Warje, Pune-411058Phone : 09881946595E-mail: (MM)BE( Mechanical)ProfessionalCertified Lead Auditor ISO 9001-2008Certified Lead Auditor ISO 13485-2003Certified Lead Auditor CE Marking for Medical devicesFaculty for ISO 13485-2003TechnicalUndergone training on IEC 60601 series ( General, Collateral and Particular standards)Undergone training on EMI/EMCUndergone training on ISO 10993 series for BiocompatibilityUndergone training on standards related to clean room maintenance and validationUndergone training on standards related to sterilizationUnderergone training on ISO 17025 and ISO 15189 for Laboratory ManagementWork Experience:5 years working experience in Orthopedic Implant manufacturing including surgical instrumentsand Medical Electronic equipments for Orthopedic surgery2 Years working experience with Urology, Gastroenterology, infertility disposables and relatedMedical equipment manufacturing3 years working experience with material handling equipments manufacturers7 years experience asa Lead auditor with different European Notified Bodies and Indian Certification bodies as afreelancer auditor ( approx 600 man-day auditing experience)Consultant for ISO 13485- 2003 and CE Marking for Medical Device manufacturersFaculty for ISO 13485-2003Technical Director for Laboratories for IEC compliance, Biocompatibility and Aging study( Accelerated/Real Time)
  2. 2. Annexure to ResumeA. Working Experience: Position Length of (Title/Function) Service Area Company time in positionIEC compliance Testing , compliance to EC directives for Astute labs Technical April 2012-general safety, EMI / EMC, Biocompatibility Testing and Pvt Ltd, Pune Director till DateAccelerated aging study/ Efficacy study Safetek JanuaryIEC compliance Testing , compliance to EC directives for Technical Laboratory, 2011 – Aprilgeneral safety, EMI / EMC Director Pune 2012IEC compliance, compliance to EC directives for generalsafety, EMI / EMC and technical guidance on establishmentof the process and validation of the processes of differentmachine manufacturers, different medical devicemanufacturers, different pressure equipment manufacturersand general electrical equipments,coordination in pre-compliance and full compliance testing.Consultancy to disposable medical device manufacturersmade up of different polymers like polyurethane, Globalpolypropylene, polyethylene , ABS, PVC by plastic injection June 2009 technology Directormoulding and plastic extrusion. till date CentreConsultancy to the manufacturers of different electrical andelectronic medical devices and general purpose machineswith processes including casting, forging, machining withthe help of CNC, VMC, Lathe and milling machine, sheetmetal work, powder coating, electrical assembly and wiring.Consultancy to heavy fabrication works, water treatmentsolutions. Zenith QualityManagement system certification and product certification Head- Product May 2008 to Assessors Pvtand third-party inspection services Certification June 2009 Ltd BMQR Certifications Pvt Ltd, Panel Auditor/ August 2007Management system certification and SWISO India Lead auditor to May 2008 Pvt Ltd Septemberproduct certification of medical device directive, machine Moody ICL 2005 todirective, low voltage directive, electromagnetic compatibility Certifications CE auditor for Septemberdirective, pressure equipment directive, personal protective Ltd a product 2006equipments directive, management system certification of certificationmedical devicesManufacturing, design and development and quality Nasan Designassurance of electro medical devices (at it embedded, Medicals manager&measuring instruments for different human body parameters June 2005 to Managementfor diagnosis and monitoring), body parameters monitoring September Representativeequipment s 2005
  3. 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 detailstraining turningprograms conducted25.01.2007 Moody ICL ISO 9001:2000 QMS - Internal / External Auditing Techniques : Lead Certifications Auditors Course - ISO 9001:2000 Quality Management System Ltd21.07.2005 Moody ICL BS 7799 ISMS Information security requirements ( ISO 27001) : BS 7799 Certifications ISMS -CIS Information security Manager ( ISO 27001) Ltd7th to 9th ITC Zlin Czech Principles and procedures according to ISO 17021October 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 Devices7th to 9th ITC Zlin Czech MDD and AIMD conformity assessmentOctober 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 DevicesThird and Centre for Course on Laboratory Competence as per ISO/IEC 17025: 2005 & Aspects offourth of May electronic test Internal Audit2008 engineering Pune
  4. 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 Pune13th and 14th ITC Zlin Czech Get acquainted with results of MSCB-3002 activity and economic frameworkmay 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 safety26 October to CERMET Italy, EC Mark 93/42/EEC and 2007/47/EC Medical Devices Directives and IS05 November 13485 requirements in auditing certification processes200923.05.2008 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 researchfourth of field sciencesJanuary 2009Sixth of National testing methods of bio compatibility of medical devices as per ISO 10993February 2009 toxicology Centre9 September Quality service Assessment of the management system as per ISO 9001, assessment of2011 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 requirements18 January 3 EC Medical device directive and CE marking approach2011 international Slovakia18th 3 EC Auditor training course as per ISO 17021
  5. 5. September international2009 Slovakia18 January 3 EC Written examination training course of ISO 9001 2008 and ISO 13485 20032011 international and medical device directives Slovakia14 September 3 EC Written examination training course of new requirements of ISO 17021 20112011 international Slovakia12 August MEYER, CE marking and new approach directives, operational procedures and2010 Turkey documents of conformity assessment of the notified body, CE marking scope of the notified bodySixth to 8 National Specifications for testing and monitoring to prove continued complianceFebruary 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 IS011135-1:2007February 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 pumpsFebruary 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