Ольга

Olga Doroguntsova
Quality Management System Manager | Medical Devices | ISO 13485
Contact Information
Email:
Phone:
Location: Kyiv, Ukraine
Profile
Experienced Quality Management System (QMS) Manager with over 5 years of expertise in the medical devices sector. Skilled in implementing and maintaining QMS in accordance with DSTU EN ISO 13485:2018, preparing technical documentation, certification dossiers, and ensuring compliance with Technical Regulations No. 753 and No. 754. Strong background in international supplier communication, foreign economic activity, document preparation for customs, and registration of medical devices with the State Service of Medicines.
Key Competencies
• Quality Management System (QMS) – ISO 13485
• Technical documentation development and certification dossiers
• Compliance with Technical Regulations No. 753 and No. 754
• Medical device registration with the State Service of Medicines
• Translation of technical, medical, legal documentation
• Supplier communication and purchase order management
• Documentation for customs clearance
• Preparation of catalogues, IFUs, supporting materials
Work Experience
DOPOMOHA-I LLC
Quality Management System Manager | February 2019 – Present
• • • Development, implementation, and maintenance of QMS according to DSTU EN ISO 13485:2018.
• • • Preparation of technical documentation for medical devices.
• • • Preparation of certification packages in accordance with Technical Regulations No. 753 and No. 754.
• • • Medical device registration with the State Service of Medicines.
• • • Preparation and maintenance of SOPs, instructions, technical files.
DOPOMOHA-I LLC
Translator / Foreign Economic Activity Manager | March 2007 – February 2019
• • • Communication with suppliers and management of purchase orders.
• • • Preparation of documentation for customs clearance.
• • • Translation of technical, legal, and medical documentation.
• • • Preparation of catalogues and Instructions for Use.
DISPOMED Manufacturing Company
Translator | December 2006 – March 2007
• • • Communication with suppliers and order coordination.
• • • Translation of commercial, legal, and technical documentation.
United Transport Holding LLC
Office Manager / Translator | August 2005 – December 2006
• • • Administrative office support.
• • • Translation of documents and correspondence.
State Pharmacological Center, Ministry of Health of Ukraine
Translator | June 2003 – August 2005
• • • Translation of pharmacological and medical texts.
• • • Preparation of materials for the website.
Lyceum of International Relations No. 51
English Teacher | December 2001 – 2003
• • • Teaching English language.
• • • Organizing extracurricular student activities.
Education
Kyiv State Linguistic University (1997–2002)
Degree in Philology, English and German Language Teacher
Languages
Ukrainian – fluent
Russian – fluent
English – fluent
Additional Skills
MS Word, Excel, Acrobat, Internet