Experience

FxOrthopedics

• Türkiye
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Engineer

  • Jun 2021 - Present

  *In the company that produces orthopedic implant and prosthesis systems(class IIb, class III); -To implement, develop and maintain the ISO 13485:2016 Quality Management System and to carry out relevant activities for the continuous improvement of the effectiveness of the system. -To document ISO 13485:2016 Quality Management System and MDD 93/42/EEC and 2017/745 MDR (EU) regulations. -Preparing technical files, following up-to-date, and doing necessary revisions. -Preparation of… Show more *In the company that produces orthopedic implant and prosthesis systems(class IIb, class III); -To implement, develop and maintain the ISO 13485:2016 Quality Management System and to carry out relevant activities for the continuous improvement of the effectiveness of the system. -To document ISO 13485:2016 Quality Management System and MDD 93/42/EEC and 2017/745 MDR (EU) regulations. -Preparing technical files, following up-to-date, and doing necessary revisions. -Preparation of quality plans, Clinic Evaluation Report, Risk analysis, PMS, PMCF, PSUR. -Evaluation of biocompatibility and biomechanical test reports and literature review. Show less



MED TIP MALZ. IHT. IHR. LTD. ŞTİ.

• Quality Management Representative

  • Aug 2020 - Jun 2021

  Çiğli, İzmir, Türkiye *In the company that produces ethylene oxide sterilizers and consumables (class II) -To implement, develop and maintain the ISO 13485:2016 Quality Management System and to carry out relevant activities for the continuous improvement of the effectiveness of the system. -To document ISO 13485:2016 Quality Management System and MDD 93/42/EEC and 2017/745 MDR (EU) regulations. -Preparing technical files, following up-to-date, and doing necessary revisions. - Production control… Show more *In the company that produces ethylene oxide sterilizers and consumables (class II) -To implement, develop and maintain the ISO 13485:2016 Quality Management System and to carry out relevant activities for the continuous improvement of the effectiveness of the system. -To document ISO 13485:2016 Quality Management System and MDD 93/42/EEC and 2017/745 MDR (EU) regulations. -Preparing technical files, following up-to-date, and doing necessary revisions. - Production control, preparing production documents and doing annual production plans. - Execution of purchasing and sales processes and input of UTS production, delivery and purchase notifications. Show less


Ayis Medikal
• Engineer Intern

  • Jul 2019 - Aug 2019

İzmir Katip Çelebi Üniversitesi Atatürk Eğitim ve Araştırma Hastanesi
• Engineer Intern

  • Jul 2018 - Aug 2018