1. Resume
Mr. Sandip Nandkumar Kulkarni
Qualification: BE (Mech) Passed With First Class In 1997 With 14+ Years
Experience with manufacturing & Certification bodies. Certified Lead auditor (IRCA approved
course) of ISO 9001-2008 , (IRCA approved Lead Auditor course) OHSAS 18001 & Information
security Management System Reviewer (ISO 27001)’, Approved Lead auditor from Indian
certification Bodies and European Certification/Notified Bodies.
Have a Working experience of ISO 17021 with certification bodies,
Have undergone Certificate training programs of ISO 17025 and ISO 15189 conducted by Quality
council of India (Government of India),
Worked as a Faculty for a training organization of Government of India for ISO 13485-2003
Worked as an auditor for more than 200 audits in India for ISO 9001-2008 and ISO 13485-2003.
Worked for CE certification of following directives:
a) Medical Device Directive (MDD 93/42/EEC) + ISO 13485-2003 ( Participated in a training
program for auditors in ITC Zlin, CERMET Italy and 3EC International in slovakia.)
b) Low Voltage Directive : 2006/95/EC
c) Electro magnetic Compatibility : 2004/108/EC
d) Machinery Directive: 2006/42/EC
e) Pressure Equipment : 97/23/EC ( Participated in a training program in Apragaz Brussels
before approval as an auditor for PED)
f) ATEX Directive: 94/15/EC + ISO 13980 + IEC EX : Independently worked on the
consultancy project by Basifa.
Strength:
a) Working experience of implementation of ISO 9001: 2008, ISO 13485:2003,and CE
certification (MDD –93/42/EEC, LVD with EMC, Machinery, PED & ATEX), ISO 14001, OHSAS
18001, ISO 27001, ISO 17025 implementation.
b) Specialization in Biocompatibility study, Clean room validation and Sterilization validation,
accelerated aging study and compliance to the different IEC standards ( IEC 60601, IEC
60335, IEC 61010, IEC 60204 series of standards)
c) Having knowledge of 5S system for cleanliness, Kaizen for better and continuous
improvement.
d) Worked as Production Manager, Design Manager, Quality Manager, Management
Representative in manufacturing and Head product certification with the certification body.
Software skills: Hands on experience of AutoCAD 2000, certificate course of Ideas master
series, Pro E 2000i, and MS office.
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2. Resume
Working experience of ERP package for QA department.
Experience Details:
a) As a CE Auditor: Support the client for identification of directive, harmonized standards &
applicable tests. Guide the client for making the technical file. conduct the audit, Other
operation work
b) As Head Product certification:
1. To carry out ISO 9001, ISO 13485, ISO 27001 & CE audits. .
2. To achieve the business development targets for Management and product
certification schemes.
3. To co ordinate with notified bodies for all the matters ( Technical & administrative
) for CE certification.
4. To conduct the initial review of the technical files received from the clients and to
assist Notified body reviewer for their review.
5. Responsible for making business association of the certification body with the
Notified bodies for CE Marking.
6. To co ordinate with accreditation bodies for all the matters ( Technical &
administrative ) for ISO 13485.
Working with
Global Technology Centre
Designation: Division Director (certification, Microbiology and Electrical safety)
Duration: Jan 2008 onwards
Job Description: Overall management of the certification activity, Management of the ISO
17025 accreditation projects
Worked with Certification bodies on a part time basis
Certification bodies meeting the requirement of ISO 17021-2006 ( Conformity assessment
requirements for bodies providing audit & certification of management system) offers
certification like ISO 9001-2008, ISO 13485-2003, ISO 14001-2001, OHSAS ISO 18001-
1999, ISO 22000-2005, ISO 27001-2006 etc.
Duration: August 2007 On words.
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3. Resume
Worked with following organization:
(Between September 2006 to August 2007, Worked as a auditor for different Certification
bodies and technical coordinator for CE Mark Certification & US FDA registration, Faculty for
an organization of Government of India for ISO 13485-2003)
Moody ICL Certifications Ltd
Certification body offers certification in QMS like ISO 9001-2000, ISO 13485-2003 etc &
Product certifications like CE certifications. The company is engaged with testing and
calibration, Third party inspection, supply chain management & Training.
Duration: September 2005 to September 2006
Designation: CE Auditor,
Job profile: a) Approved CE and ISO 13485-2003 auditor, conducted more than 34 CE
certification audits all over India. worked as a Technical expert for Medical devices system
audits. Guide client to identify the directive, harmonized standards, applicable tests, risk
analysis with evaluation & preparation of the technical file.
b) Working as a technical coordinator with the organizations for compliance of their
products with the essential safety requirements of the applicable directives ( e.g. Thermax
India Ltd)
c) conducted More than 34 initial certification audits for CE Marking certification. worked as
an observer in the Third Party Inspection project.
d) As a technical coordinator, Worked closely with the clients of ICL certifications limited,
Gone through the following standards:
Examination gloves: single time medical use: ISO 11193; Sterile rubber gloves for single
time use: ISO 10282; General requirements for gloves: EN 455; Implants for surgery:
Suture wire: ISO 10334; ISO 5840: Cardiovascular Implants; 5841: cardiac Pace maker;
ISO 11318: Cardiac defibrillators; ISO 7864: Sterile hypodermic needles for single use;
Needle tube: ISO 9626; ISO 10555 Intravascular catheters; Anesthesia workstation: EN
740; Lung ventilator: EN 794ISO 11607: General requirements of packing of sterile devices;
EN 868: packing of medical devices
Nasan Medicals
Manufacturer of PC based cardiac diagnoses systems
Duration: June 2005 to September 2005
Designation: Design manager& Management Representative
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4. Resume
Job Profile : a) To guide a team of Design engineers & inspectors for QA activities( as
mentioned above),
b) All functions of MR. Appointed for CE certifications activity.
c) Worked as an internal quality auditor & coordinator
d) Technical coordinator for Risk assessment, Mitigation process, Meeting essential safety
requirements & identification with implementation of the general & particular requirements
of the applicable standards: IEC 60601-1-1 & IEC 60601-1-2, 2-25,51: For ECG based
machines, 2-49 for multi parameter monitors, 2-30 for NIBP etc.
R&D TECH INC
Manufacturer of Urological stents and catheters, Pneumatic lithotripsy systems
Duration: April 2005 to june 2005
Designation: a) In charge of QA dept. and MR
Job Profile : To guide a team of inspectors for QA activities ( as mentioned above), All
functions of MR.
b) In charge Engineering (Design and development and QA activities)
Job Profile : To guide a team of engineers for Design and development and Engineering
activities ( as mentioned above), Preparation of CE Technical file.
Worked as an internal quality auditor & technical coordinator for monitor & control the EtO
sterilizer & clean room. (EN 550: ETO sterilization ( requirement & validation), ISO 14644:
protocol & testing method for Clean room)
S.H.Pitkar Orthotools Pvt. Ltd.
Manufacturer of precise medical devices, jigs/fixtures & Instruments. It is a complete CNC
shop includes very precise turning centers and machining centers (Takamatsu, Murata,
Tornus, Cincom, NTC, BMC and many SPMs with Elpro controllers). They have a well
equipped QA department with Optical profile(with DRO), Height master (up to 2D :
Electronica Make: model : Optima), hardness testers, a variety of measuring instruments,
gauges, checking fixtures and calibration gauges(WCPs)
Duration: June 2000 to April 2005
Designation: a) In charge of QA dept. and MR
Job Profile : To guide a team of inspectors for QA activities( as mentioned above), All
functions of MR.
b) In charge Engineering (Design and development and QA activities)
Job Profile : To guide a team of engineers for Design and development and Engineering
activities ( as mentioned above), Preparation of CE Technical file.
Worked as an internal quality auditor & Technical coordinator. Referred following standards
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5. Resume
Implants for surgery: Stainless steel & Titanium ISO 5832-1(316L), 2 & 3, General
requirements of surgical instruments with blades : ISO 7740, General method of testing of
surgical instruments with blades: ISO 7741 , General requirements of non cutting
instruments: ISO 7151; Surgical instruments ( Stainless steel) ISO 7153;Non destructive
testing of cast implants ( X ray testing): ISO 9584: Implants for surgery: Joint replacement
ISO 21534 ( Initially it was in class IIb but now it is class III products ( As per annexure IX
of MDD 93/42/EEC)
As the sterilization with Gamma irradiation process was outsourced, Worked with the
supplier for ISO 11137.
Autotech Industries
Manufacturer of material handling equipments, manufacturer of different types of jig,fixture.
Duration:10 September 1999 to 10 June 2000
Designation: Process development engineer (combined activity of production and QA dept).
Job Profile : To guide a team of skilled workers and graduate level inspectors.
Worked as an internal auditor & coordinator
Intelligent conveyors and stackers pvt Ltd.
Manufacturer of overhead conveyors (caterpillar Type), Vertical carousal system ( working
with the PPLCs) and mechanical lifter system for 7 tank treatment. They have a heavy duty
fabrication, assembly & sheet metal fabrication and a big conventional machine shop.
Duration: 19th September 1997 to 10 September 1999
Designation: Production Engineer, member on development committee.
Job Profile : To guide a team of skilled workers to perform the production activities.
Personnel details:
Name Sandip Nandkumar Kulkarni
Date Of Birth 13th August 1974
Phone Number and E mail ID +91-9881946595 mail2sandipk@gmail.com
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