Alexander Osetskiy

Angestellt, Quality Assurance, Looking for new opportunities

Any city, Deutschland

Fähigkeiten und Kenntnisse

Quality management systems
ISO 13485
ISO 14001
ISO 9001
Medical device regulations
MDD 93/42
FDA CFR 21
GMP
Medical devices risk management
ISO 14971
IEC 60601
Medical software
IEC 62304
Lean
Six Sigma
FMEA
Verification and validation
Corrective and preventive actions
FDA
CE
Regulatory affairs
Quality assurance
X-Ray
Medical imaging
Standards
R&D
Process reengineering
Certification
Testing
Audits
Authorized bodies
PACS
DICOM
HL7
EHR
Human factors
Usability
Device technical files
Clinical trials
Philips Healthcare
Project management
New product introduction

Werdegang

Berufserfahrung von Alexander Osetskiy

  • Bis heute 8 Jahre und 6 Monate, seit Jan. 2016

    Quality Assurance

    Looking for new opportunities

  • 2 Jahre, Jan. 2014 - Dez. 2015

    Process analyst

    WA Ethnic Centre, Perth, Western Australia

    - Improved educational processes, such as enrolment and scheduling - Designed a collaborative website and tracked the content - Performed user acceptance testing - Supported digital customer experience - Resolved a number of problems the Centre experienced in communicating relevant and timely information to relevant audience

  • 6 Monate, Juli 2013 - Dez. 2013

    Quality analyst

    Department of Planning, Perth, Western Australia

    - Investigated and compared international best practice processes - Discovered gaps and weaknesses in the government system - Elaborated principles, structure and workflow for the new processes - Coordinated requirements and outcomes with stakeholders - Prepared reports and provided presentations to management

  • 4 Jahre und 11 Monate, Jan. 2008 - Nov. 2012

    Quality Assurance Coordinator

    NIPK Electron, St. Petersburg, Russia

    - Implemented and documented quality management system - Implemented risk management process - Monitored legal requirements changes and controlled addressing them - Trained staff on the new processes - Conducted regular internal and external audits - Consulted a supplier on quality issues (Roesys GmbH, Germany) - Assisted the company to receive permissions to deliver its systems to Europe, USA and China markets - Supported NPI of computer tomography systems in collaboration with Philips Healthcare

  • 5 Jahre und 3 Monate, Okt. 2002 - Dez. 2007

    Quality Assurance Coordinator

    Solvo, St. Petersburg, Russia

    - Implemented and documented quality management system - Established all key procedures, templates and responsibilities - Implemented new processes on the continuous basis - Arranged systematic activities related to defect records and correction

  • 2 Jahre, Okt. 2000 - Sep. 2002

    Software quality assurance engineer

    Devexperts, St. Petersburg, Russia

    - Developed test plans and test cases - Implemented system tests - Documented end-user materials - Analysed and tracked customer issues

Ausbildung von Alexander Osetskiy

  • 2013 - 2015

    Management Information Systems

    Edith Cowan University, Western Australia

  • 1993 - 1996

    Systems Engineering

    University of Nuclear Power Engineering, Russia

Sprachen

  • Englisch

    Fließend

  • Russisch

    Muttersprache

Interessen

Coauthor of 7 scientific papers and a patent in the area of nuclear power system reliability

21 Mio. XING Mitglieder, von A bis Z