Experience

DeSia Clinical Research

• Türkiye
• Research Services
• 1 - 100 Employee

• Quality Management Representative and Regulatory Submissions Responsible

  • Feb 2019 - Present

  • Manage quality operations as per ISO 9001 and EN ISO 13485 • Responsible for the regulatory submission management of clinical trials conducted. • Responsible for review of Post Market Clinical Follow-up (PMCF) plans as per MDR requirements • Responsible for review of Clinical Evaluation Plans & reports as per MDR requirements • Manage quality operations as per ISO 9001 and EN ISO 13485 • Responsible for the regulatory submission management of clinical trials conducted. • Responsible for review of Post Market Clinical Follow-up (PMCF) plans as per MDR requirements • Responsible for review of Clinical Evaluation Plans & reports as per MDR requirements



AdviQual

• Türkiye
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Founder at AdviQual

  • Jul 2015 - Present

  AdviQual is your solution partner, if you are operated in highly regulated industries. At every stage your processes, we provide strategic guidance, trainings and support to help you improve your processes. While doing our job, we place value on seeking long-term solutions We serve as your trusted and reliable, solution partner, using our insight to identify strategies for saving time, while never compromising quality. We give consultancy and sell products to obtain better Quality and contrinous improvement for highly regulated industies. Show less



Alvimedica

• Türkiye
• Medical Device
• 100 - 200 Employee

• Quality Coordinator

  • Dec 2013 - Jun 2015

  Manage quality operations for 3 manufacturing and R&D centers of Alvimedica - Turkey, Holland and Italy Responsible for the quality system globalization and managing 3 sites under one unite quality system Leader for FDA approval Project for the products manufactured by Alvimedica Manage quality operations for 3 manufacturing and R&D centers of Alvimedica - Turkey, Holland and Italy Responsible for the quality system globalization and managing 3 sites under one unite quality system Leader for FDA approval Project for the products manufactured by Alvimedica



Bıçakcılar Tıbbi Cihazlar San. A.Ş.

• Quality Director

  • Mar 2011 - Aug 2013

  Member of Executive Committee Managing quality operations including ISO 9001, ISO 13485, ISO 17025, ISO 14001 and 93/42/EEC Directive. Implemented solutions that improve revenue generation of Bıçakcılar Laboratuvar Medikal A.Ş.to enhance profitability. Member of Executive Committee Managing quality operations including ISO 9001, ISO 13485, ISO 17025, ISO 14001 and 93/42/EEC Directive. Implemented solutions that improve revenue generation of Bıçakcılar Laboratuvar Medikal A.Ş.to enhance profitability.



Bicakcilar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

• Medical Device
• 1 - 100 Employee

• Laboratory Coordinator

  • Jan 2005 - Feb 2011

  Responsible for the management of Laboratory activities.Responsible for resource planning for the LaboratoryResponsible for the communication with the customers about the tests and consultancy activities.Implemented solutions that improve revenue generation to enhance profitability.Negotiated with business partners for mutual benefits.

• Manufacturing Quality Assurance Manager

  • Jan 2003 - Jan 2005

  Head of a team for the project of accreditation of Bıçakcılar Laboratory as per ISO 17025 for performing approved tests for the third partiesResponsible for CE marking and ISO 13485 application of Bıçakcılar A.Ş. disposable medical devices.Responsible for the coordination of product technical files, Laboratory Applications, Corrective and Preventive Actions.Responsible for the coordination of Change Management System in Bıçakcılar.Responsible for the advisory notices and relation of Bıçakcılar with the Turkish Healthy Ministry about national Medical Device Industry regulations.Responsible for customer complaints and recalls.Participate in a team for the product Risk Management.Responsible for the coordination of Nonconforming products.Responsible for the communication of the Quality issues with the Authorized Representative, Notified Body and foreign customers.Participate in a team for implementation of Quality Management System software in the factory. Show less

• Quality Control Laboratory Manager

  • Jan 2001 - Jan 2003

  Responsible for al the quality control activities for disposable medical devicesn Responsible for all the validations in the factory.Responsible for implementing of Good Laboratory Practices (GLP) in the laboratory and Good Manufacturing Practices (GMP) in the factory.Responsible for the foreign company relation about the quality issues.Head of a team for implementing statistical control in all stages of production.

• Microbiology Laboratory Supervisor

  • Sep 1999 - Dec 2000

  Responsible for validations and hygiene within the company.Responsible for the routine tests done like sterility, LAL, clean room monitoring etc.Provide training for validation and hygiene for the personnel.Responsible for the implementation of Good Laboratory Practices in the laboratory.Responsible for the foreign company relation about the quality issuesnMember of the quality team, provided research and development assistant.