Ecem Merve Dursun
Quality Management Representative at Erfadent Diş Malz. İth. İhr. San. Ve Tic. Ltd. Şti.- Claim this Profile
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İngilizce Professional working proficiency
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Almanca Elementary proficiency
Topline Score
Bio
Pervin Akarsu
İş hayatım boyunca bir şekilde yolumuz kesişerek beraber çalışma fırsatı yakaladığım MERVE'lerden dolayı çok şanslı olmuşumdur...🤗 Ecem Merve'nin de firmamız kalite departmanında görev yaptığı süreçlerde; araştırmacı, inisiyatif alan, yeniliklere açık, sonuç odaklı, tek yada ekiple çalışmaya yetkin ve uyumlu özellikleri dikkat çekmiştir. Tavsiye edebilirim. Saygılarımla Pervin
Hasan Basri DURSUN
It is not easy to come across a talent like Ecem Merve Ersöz. Specializing in the medical device industry, she has unmatched ability to handle ISO, CE and FDA regulations. If there is someone who entertains both herself and her teammates while working even in a very busy work schedule, Ecem is the room. Ecem Merve Ersöz is someone who will inspire any team; every company that gets the opportunity to work with her is very lucky…
Pervin Akarsu
İş hayatım boyunca bir şekilde yolumuz kesişerek beraber çalışma fırsatı yakaladığım MERVE'lerden dolayı çok şanslı olmuşumdur...🤗 Ecem Merve'nin de firmamız kalite departmanında görev yaptığı süreçlerde; araştırmacı, inisiyatif alan, yeniliklere açık, sonuç odaklı, tek yada ekiple çalışmaya yetkin ve uyumlu özellikleri dikkat çekmiştir. Tavsiye edebilirim. Saygılarımla Pervin
Hasan Basri DURSUN
It is not easy to come across a talent like Ecem Merve Ersöz. Specializing in the medical device industry, she has unmatched ability to handle ISO, CE and FDA regulations. If there is someone who entertains both herself and her teammates while working even in a very busy work schedule, Ecem is the room. Ecem Merve Ersöz is someone who will inspire any team; every company that gets the opportunity to work with her is very lucky…
Pervin Akarsu
İş hayatım boyunca bir şekilde yolumuz kesişerek beraber çalışma fırsatı yakaladığım MERVE'lerden dolayı çok şanslı olmuşumdur...🤗 Ecem Merve'nin de firmamız kalite departmanında görev yaptığı süreçlerde; araştırmacı, inisiyatif alan, yeniliklere açık, sonuç odaklı, tek yada ekiple çalışmaya yetkin ve uyumlu özellikleri dikkat çekmiştir. Tavsiye edebilirim. Saygılarımla Pervin
Hasan Basri DURSUN
It is not easy to come across a talent like Ecem Merve Ersöz. Specializing in the medical device industry, she has unmatched ability to handle ISO, CE and FDA regulations. If there is someone who entertains both herself and her teammates while working even in a very busy work schedule, Ecem is the room. Ecem Merve Ersöz is someone who will inspire any team; every company that gets the opportunity to work with her is very lucky…
Pervin Akarsu
İş hayatım boyunca bir şekilde yolumuz kesişerek beraber çalışma fırsatı yakaladığım MERVE'lerden dolayı çok şanslı olmuşumdur...🤗 Ecem Merve'nin de firmamız kalite departmanında görev yaptığı süreçlerde; araştırmacı, inisiyatif alan, yeniliklere açık, sonuç odaklı, tek yada ekiple çalışmaya yetkin ve uyumlu özellikleri dikkat çekmiştir. Tavsiye edebilirim. Saygılarımla Pervin
Hasan Basri DURSUN
It is not easy to come across a talent like Ecem Merve Ersöz. Specializing in the medical device industry, she has unmatched ability to handle ISO, CE and FDA regulations. If there is someone who entertains both herself and her teammates while working even in a very busy work schedule, Ecem is the room. Ecem Merve Ersöz is someone who will inspire any team; every company that gets the opportunity to work with her is very lucky…
Credentials
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PRODUCTION QUALITY STANDARDS
Boğaziçi ÜniversitesiDec, 2022- Oct, 2024 -
EU 2017/745 - MDR (TIBBİ CİHAZ YÖNETMELİĞİ)
AdviQualNov, 2022- Oct, 2024 -
STRATEJİK İLİŞKİ VE İLETİŞİM YÖNTEMİ
İMMİB AkademiApr, 2022- Oct, 2024 -
TURQUALITY VE YURT DIŞI BİRİM DESTEKLERİ
İMMİB AkademiApr, 2022- Oct, 2024 -
İŞYERİNDE İLETİŞİM VE STRES YÖNETİMİ
İMMİB AkademiApr, 2022- Oct, 2024 -
KÖK NEDEN ANALİZİ
İMMİB AkademiOct, 2021- Oct, 2024 -
MICROSOFT POWER BI
İMMİB AkademiOct, 2021- Oct, 2024 -
İLERİ WORD UYGULAMALAR
İMMİB AkademiSep, 2021- Oct, 2024 -
İŞ SAĞLIĞI VE GÜVENLİĞİ (İSİG)
İMMİB AkademiSep, 2021- Oct, 2024 -
ZİHİN HARİTALAMA (MIND MAPPING)
İMMİB AkademiAug, 2021- Oct, 2024 -
İŞYERİNDE İLETİŞİM VE İLİŞKİLERDE DUYARLILIK
İMMİB AkademiAug, 2021- Oct, 2024 -
SATIŞTA İLETİŞİM
İMMİB AkademiJul, 2021- Oct, 2024 -
ISO 14001:2015 ÇEVRE YÖNETİM SİSTEMİ
İMMİB AkademiMay, 2021- Oct, 2024 -
DİKSİYON, ARTİKÜLASYON VE ETKİLİ İLETİŞİM
WorkshopersMar, 2021- Oct, 2024 -
GÜVENLİK BİLGİ FORMU OKUYUCULUĞU
TMMOB Kimya Mühendisleri Odası / UCTEA Chamber Of Chemical EngineersMar, 2021- Oct, 2024 -
KALİBRASYON VE KALİBRASYON PERİYODU BELİRLEME (KALİBRASYON SERTİFİKALARININ DEĞERLENDİRİLMESİ)
TMMOB Kimya Mühendisleri Odası / UCTEA Chamber Of Chemical EngineersMar, 2021- Oct, 2024 -
GHP,İYİ HİJYEN UYGULAMALARI (Good Hygiene Practice)
YaşamartıSep, 2014- Oct, 2024 -
GLP,İYİ LABORATUVAR UYGULAMALARI (Good Laboratory Practice)
YaşamartıSep, 2014- Oct, 2024 -
GMP,İYİ ÜRETİM UYGULAMALARI (Good Manufacturing Practice)
YaşamartıSep, 2014- Oct, 2024 -
ISO/IEC 17025 Kalibrasyon ve Test Laboratuvarları Akreditasyonu
YaşamartıSep, 2014- Oct, 2024
Experience
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Erfadent Diş Malz. İth. İhr. San. Ve Tic. Ltd. Şti.
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Türkiye
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Management Representative
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Mar 2023 - Present
Erfadent manufactures dental implants and conducts worldwide distribution of these products. I am currently responsible for: Obtaining CE (MDR/2017/745/EU) certification. Organizing and managing audits to ensure continuity Ensuring traceability of products Obtaining and maintaining the Post Sales Service Qualification Certificate (SSHYB) Making UTS notifications and registrations of products Erfadent manufactures dental implants and conducts worldwide distribution of these products. I am currently responsible for: Obtaining CE (MDR/2017/745/EU) certification. Organizing and managing audits to ensure continuity Ensuring traceability of products Obtaining and maintaining the Post Sales Service Qualification Certificate (SSHYB) Making UTS notifications and registrations of products
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Quality Management Representative
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Mar 2021 - Mar 2023
Üzümcü Hastane Ekipmanları manufactures medical materials (class IIa and IIb medical devices) in the fields of Operating Tables/Stainless Steel Hospital Equipments/Medical Gas Systems(Kryo Therapy Device/Aspirators/ Vacuum System/Vacuum Station/Bedside Unit/Pendant System/Regulators/Medical Jack/Medical Socket/ Medikal Valve/ Anesthesia Gas Evacuation System(AGSS)/ Area Gas Control Unit/ Oxygen Therapy Device/ Flowmeter/Gas Plants) and conducts worldwide distribution of these products. I am currently responsible for: Obtaining CE (MDR/2017/745/EU) and ISO 13485:2016 / ISO 9001:2015 / ISO 14001:2015 / ISO 45001:2018 certification. Organizing and managing audits to ensure continuity. Obtaining and maintaining the Service Qualification Certificate (TSE HYB) Obtaining and maintaining the Post Sales Service Qualification Certificate (SSHYB) Making UTS records of products. Continuously check and update technical files, Quality Manual. Internal audits | Nonconformity determination| CAPA Registration of products in the Eudamed Database Experienced in; QMS (ISO 13485:2016) Design and Development Risk Analysis (ISO 14971:2019 & ISO 24971) CER (ISO 14155:2011/MEDDEV 2.7.1 rev04) Market Surveillance - Vigilance Systems (MEDDEV 2.12.1 rev.08) Product Tracking System (UTS) Service Qualification Certificate (TSE HYB) Post Sales Service Qualification Certificate (SSHYB) Eudamed Database Show less
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Akmeda Medikal
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Türkiye
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Management Representative
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Jan 2021 - Mar 2021
Akmeda Medikal manufactures medical products (class Is medical devices) in the fields of surgical gowns/surgical drapes and conducts worldwide distribution of these products. Akmeda Medikal manufactures medical products (class Is medical devices) in the fields of surgical gowns/surgical drapes and conducts worldwide distribution of these products.
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Quality Management Representative
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Nov 2019 - Jan 2021
TTT World manufactures medical materials (class IIa medical devices) in the fields of Syringe/ Infusion Set/ Blood Tube and conducts worldwide distribution of these products. I am currently responsible for: Obtaining CE (MDD/93/42/EEC) and ISO 13485:2016 certification. Organizing and managing audits to ensure continuity. Making UTS records of products. Continuously check and update technical files, Quality Manual. Internal audits | Nonconformity determination| CAPA Experienced in; QMS (ISO 13485:2016) Design and Development Risk Analysis (ISO 14971:2019 & ISO 24971) CER (ISO 14155:2011/MEDDEV 2.7.1 rev04) Market Surveillance - Vigilance Systems (MEDDEV 2.12.1 rev.08) Product Tracking System (UTS) Show less
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Düzey Medical
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Türkiye
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Medical Device
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1 - 100 Employee
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Chemical Engineer
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Sep 2018 - Aug 2019
Düzey Medikal manufactures medical materials (class IIb implantable devices and class III devices) in the fields of General Surgery/ Neurosurgery/ Urology/ Urogynecology and conducts worldwide distribution of these products. I am currently responsible for: Organizing and managing audits for CE (MDD/93/42/EEC) and ISO 13485:2016 certification. Continuously check and update technical files, Quality Manual. Internal audits | Nonconformity determination| CAPA Experienced in; QMS (ISO 13485:2016) Design and Development Risk Analysis (ISO 14971:2019 & ISO 24971) CER (ISO 14155:2011/MEDDEV 2.7.1 rev04) Market Surveillance - Vigilance Systems (MEDDEV 2.12.1 rev.08) Previously responsible for; Registration of the products in different countries to enable the export business. Providing the documents which can be very specific for each MOH of the countries, and following up the registration process from the beginning to the end. I also represented my company at the international Medical Trade Fairs Show less
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Intern
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Aug 2016 - Sep 2016
I spent an internship period where I learned about production processes, production equipment, raw materials and types, quality control and quality assurance procedures and working principles of your company. I spent an internship period where I learned about production processes, production equipment, raw materials and types, quality control and quality assurance procedures and working principles of your company.
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Intern
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Jul 2015 - Aug 2015
I spent internship working in both product control and packaging control laboratories. I spent internship working in both product control and packaging control laboratories.
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Education
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2012 - 2018
Gazi Üniversitesi
Lisans Derecesi, Kimya Mühendisliği -
2021 - 2025
İstanbul Üniversitesi
Lisans Derecesi, İş Sağlığı ve Güvenliği -
2020 - 2022
Mersin Üniversitesi
Yüksek Lisans (Master), Kalite Yönetimi -
2019 - 2021
Anadolu Üniversitesi
Önlisans Derecesi, İşletme Yönetimi -
2008 - 2012
Eyüp Aygar Anadolu Lisesi
High School Education
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