Ali Bora Bingöl work email
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Ali Bora Bingöl personal email
I have been in the quality sector since 2004. I have worked in all major quality branches as a consultant, auditor, operator, trainer and sometimes as the company owner or manager e.g. quality management systems, product quality systems, calibration, testing and inspection.I am a senior consultant for medical devices CE marking for the past 12 years. I have striven through medical devices’ CE marking issues thanks to my previous experiences and fast learning skills; i.e. classification, biological evaluation, sterilization validation, clean room validation, clinical evaluation, risk analysis, stability, drug combined medical devices etc. and justifications for all those if need to be.I am also an auditor on construction products CE marking for the past 9 years conducting audits for system 1 and system 2 products according to CPD and CPR.I am a popular science lover, sci-fi fan, devoted trekkie with a gusto for 80’s music and classic rock.MOTTOJack of all trades, master of some.
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Business Development Manager1010Istanbul Jan 2024 - PresentIstanbul, TürkiyeImprovement of client business processes, client communication methods, internal communication and coordination, quality, productivity, efficiency and business tools, planing of project work flow, sales and marketing meetings, potential/new client and sector studies, content creating -
Quality Manager, Busniness Development ManagerCompo Dental A.Ş. Jan 2020 - PresentIstanbul, TurkeyQM and QMR after consulting the firm for a class IIa medical device (dental composites) for 2 years. Held the responsibilites for quality management, quality assurance and regulatory affairs.Dental composites marketing and business development for national and international markets. Successfully managed sales and distrubiton in Egypt and some other ME countries.
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Owner, Freelance Consultant, AuditorBora Bingol Consultancy Nov 2013 - PresentTurkeyMedical devices CE marking specialist. Offering consultancy services for;- Product certification in general (i.e., CE marking and TSE brand),- Accreditation topics (ISO 17020, ISO 17025),- Technical file (CE marking),- Factory Production Control Manual (CPR & TSE brand)- Literature search reporting (MEDDEV)- Clinical evaluation (MEDDEV)- Risk analysis (MEDDEV & ISO 14971)- Sterilization validation,- Clean room validation (ISO 14644 series),- Official registration of medical devices in Turkey.
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Lead Auditor, Compliance Auditor, Project PartnerNaviga Certification Services Ltd. Jan 2014 - Dec 2023Istanbul, TurkeyConduct system 1 and system 2 audits according to Construction Products Regulation (CPR) and directive (CPD) for Naviga Certification Services Ltd. on behalf of DEDAL Attestation and Certification (NB 1922, Bulgaria), including ISO IEC 17025 audits on client’s ITT competency for system 1 products.
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Quality Manager, Business Development ManagerNeotec Biyoteknoloji San. Ve Dış Tic. Ltd. Şti. Jan 2019 - Dec 2019Istanbul, TurkeyQM and QMR after consulting the firm for a class IIa medical device (PRP kit w/o anticoagulant) for 4 years. Held the responsibilites for quality management, quality assurance and regulatory affairs. PRP kits marketing and business development for export. -
Product Managerİmmun Gida İlaç Kozmeti̇k San. Ti̇c. Ltd. Şti̇. Nov 2015 - May 2017Istanbul, TurkeyProduct manager for all types of homeostatic agents of Ankaferd Bloodstopper particularly dealing with regulatory affairs, helping market researchs and implementing quality management systems at outsourced production sites.
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Quality Management Representativeİmmun Gida İlaç Kozmeti̇k San. Ti̇c. Ltd. Şti̇. Nov 2013 - Oct 2015Istanbul, TurkeyQMR after consulting the firm for a class III medical device (Ankaferd Bloodstopper Sponge Gauze) for 2 years. Held the responsibilites for quality management, quality assurance and regulatory affairs.
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Shareholder, Trainer, ConsultantEce Sertifikasyon Tic. Ltd. Sti. Jan 2011 - Dec 2014Antalya, TurkeyShareholder, trainer and consultant conducting trainings about management systems, CE marking, TSE/TSEK brand (product certification), TSE service competency certification (TSE-HYB) and trainings about accreditation of system & product certifications, calibration and inspection.
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Process Mechanics SupervisorTuprag Metal Madencilik San. Ve Tic. A.S. Oct 2011 - Apr 2012Izmir, TurkeyWorked in Efemcukuru gold mine, at the process plant where crushing, grinding, floatation and gravitation takes place. Quit work to complete a medical device project (Ankaferd Bloodstopper Sponge Gauze, class III medical device CE marking) at ECE Sertifikasyon Ltd. when my contract came to end. Also joined the mine rescue team.
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Field InterpreterTuprag Metal Madencilik San. Ve Tic. A.S. – Adecco Apr 2011 - Oct 2011Izmir, TurkeyInterpreting and assistance for the training and engineering activities of a subcontractor consulting/training company which trains all the staff of the ore processing plant for all required tasks for their jobs. -
Consultant, Trainer, Lab ManagerEce Test Deney Ve Olcum Hizmetleri Tic. Ltd. Sti. May 2010 - Jan 2011Antalya, TurkeyConducted trainings and consultancy services for CE marking, TSE brand (product certification), aggregate tests and Factory Production Control System (EN 12620) at the test body which is a partner lab of TSE (Turkish Standards Institute) about aggregates and concrete tests. I was also the technical manager of the lab.
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Management Representative, Lab ManagerEce Kalibrasyon Validasyon Ve Olcum Hizmetleri Tic. Ltd. Sti. Jan 2010 - Jan 2011Antalya, TurkeyImplemented and managed the laboratory management system of the calibration lab and inspection body according to the standards ISO/IEC 17020 and ISO/IEC 17025. The lab’s calibration scope was heat, pressure, non-automatic weighing instruments, pH and dimension. The lab’s inspection scope was particle measurement and validation of clean rooms according to ISO 14644 series standards.
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Owner, Consultant, TrainerEce Kalibrasyon Ve Uluslararasi Belgelendirme Danismanligi Tic. Ltd. Sti. Mar 2006 - Jan 2011Antalya, TurkeyOne of the owners of the company and also chief technical officer, consultant and trainer; i.e. ISO 9001 QMS, ISO 14001 EMS, OHS management systems, food safety (HACCP, ISO 22000), CE marking, TSE/TSEK brand (product certification), TSE service competency certification (TSE-HYB), calibration and testing.The company was divided and three new companies were established (ECE Kalibrasyon Ltd. for calibration and inspection, ECE Test Ltd. for testing, ECE Sertifikasyon Ltd. for certification and training). Experiences related to those companies are mentioned above.
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Operation Chief, Quality Management RepresentativeDas Sertifikasyon Ltd. Sti. Nov 2004 - Feb 2006Izmir, TurkeyThe management of the whole certification operation (e.g. application, contracts, audit planning, customer relations, review of audit reports, management of certification process, accreditation etc.) reporting to administration manager at DAS Sertifikasyon Ltd. Şti., the Turkish agency of DAS Certification Ltd., UK (UKAS 127). Also, carried out the tasks of ISO 9001 auditor and auditor interpreter.Prepared and implemented the certification body management system (EN 45012) of the sister company KAS Sertifikasyon Ltd. Şti. for system certification accreditation from TURKAK and UKAS. Attended the witness audit of DAS Sertifikasyon Ltd.Sti. conducted by UKAS. Resigned due to establishing my own consultancy company.
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Sales Representative, Service ChiefFuzyon Bilgisayar May 2002 - Jan 2004Yalova, TurkeyService, maintenance and sales tasks as the service chief and sales representative. It was a part time job for the first six months. Quit job because of new career opportunity and change of location.
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News EditorYalova Manset Newspaper May 2001 - May 2003Yalova, TurkeyCarried out tasks like news editing and design of a local newspaper in Yalova. Prepared private interviews, news series and files. The last six months of this job was part time. Quit job to improve my experience in IT.
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Technical TranslatorUniversal Dil Hizmetleri A.S. Mar 1999 - Aug 2000Istanbul, TurkeyTranslated technical texts of automotive, electrics, electronics and advertorial texts of communication electronics, IT and automotive from English to Turkish. Quit job due to change of location.
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Weapon Electronics OfficerWar Fleet, Tcg Karadeniz Commandership (F – 255) Sep 1998 - Mar 1999Kocaeli, TurkeyWeapon electronics branch officer of the ocean escort frigate TCG Karadeniz with the same duties like the previous post.
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Weapon Electronics OfficerWar Fleet, Tcg Kilicalipasa Commandership (D – 349) Feb 1998 - Sep 1998Kocaeli, TurkeyPlanned maintenance management, conducted fault location, fault isolation, repair, maintenance and reporting of weapon systems (sonar, fire control radar, surface and underwater fire control systems, artillery and guided missiles) of the destroyer escort TCG Kilicalipasa as the commanding officer of Weapon Electronics Branch, reporting to Weapons Officer. Also, in charge of the ship hull metal works. Executed Officer of the Deck (OOD) and Watch Officer (WO) duties as well. Quit job due to assignment to TCG Karadeniz.
Ali Bora Bingöl Skills
Ali Bora Bingöl Education Details
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Turkish Naval AcademyComputer Science -
Turkish Naval AcademyComputer Engineering
Frequently Asked Questions about Ali Bora Bingöl
What company does Ali Bora Bingöl work for?
Ali Bora Bingöl works for 1010istanbul
What is Ali Bora Bingöl's role at the current company?
Ali Bora Bingöl's current role is Jack of all trades, master of some.
What is Ali Bora Bingöl's email address?
Ali Bora Bingöl's email address is bo****@****ite.com
What schools did Ali Bora Bingöl attend?
Ali Bora Bingöl attended Turkish Naval Academy, Turkish Naval Academy.
What skills is Ali Bora Bingöl known for?
Ali Bora Bingöl has skills like Ce Marking, Product Certification, Iso 13485, Iso 17025, Iso 9000, Iso 14644, Consulting, Calibration, Validation, Testing, Training, Accreditation.
Who are Ali Bora Bingöl's colleagues?
Ali Bora Bingöl's colleagues are Asrın Demir, Murat Nuri Ramadanoğlu, Ceyda Cömert, Gizem Gültekin, Sudenur Dönmez, Sezgin Kiziroğlu, Cansu Gelibolu.
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