Володимир

Volodymyr Prystaiko
Senior Test Engineer
Executive Summary

I am results-driven Senior Test Engineer with 9+ years of experience delivering quality assurance
across regulated medical device software (7+ years), life and health insurance platforms, food delivery
systems, and commercial sales platforms. Proven ability to lead test teams, drive Computerized System
Validation (CSV) initiatives, and ensure compliance in highly regulated environments.

I am a quick learner, responsible, diligent, and hardworking person and I can show the best result in
challenging situations. Besides, I am friendly, I have a good sense of humor; I am a communicative
person, so I always like to be a part of a team. I can work under pressure and overtime with new
technologies because I understand that it is important and necessary.

Key Skills & Competencies

Medical Device Software Testing - Hands-on experience with glucose sensors, insulin pumps, blood
donor collection devices, and early-stage cataract detection systems

Computerized System Validation (CSV) - Extensive expertise in validation of regulated software
systems in compliance with known standards Requirements Engineering - Skilled in eliciting,
analyzing, and documenting User Requirements Specifications and Functional Requirements
Specifications

Test Team Leadership - Experienced in managing and mentoring test teams across projects of varying
scale
Versatile QA Contributor - Effective both as a sole QA engineer on a project and as part of large,
distributed test organizations
Cross-industry Experience - Background spanning medical technology, life & health insurance, e-
commerce, and food delivery platforms
Skills QA:

Requirements Writing & Analysis - gathering, analyzing, and clarifying business and technical
requirements, identifying gaps and potential risks.
Test Design Specifications - creating test strategies, test plans, and detailed test design documentation
for functional and integration testing.
Test Case Development - designing and maintaining test cases, checklists, and test scenarios for web,
mobile, desktop and embedded applications.
Test Execution - performing functional, integration, smoke, sanity, and exploratory testing, analyzing
test results, and validating releases.

Defect Reporting - identifying, documenting, and tracking defects in bug-tracking systems,
collaborating with development teams on issue resolution.

Regression Testing - executing regression testing to ensure application stability after changes and new
feature implementations.

Network Technologies (TCP/IP, HTTP) - solid understanding of networking concepts, HTTP/HTTPS
protocols, and client-server communication.

Client-Server Architecture - understanding of frontend/backend interaction, data flow, and distributed
system architecture.
API Testing - testing REST APIs using Postman and similar tools, validating requests, responses, and
integrations.
Embedded Testing - testing embedded systems and validating software interaction with hardware
components.

Mobile Testing -testing Android and iOS applications across different devices and OS versions.
MS SQL / MySQL / PostgreSQL - writing SQL queries for data validation, troubleshooting, and
backend verification.
Methodologies: Agile, Scrum, Kanban - experience working in Agile environments with cross-
functional teams and iterative development processes.

Previous project
Project1:
Computerized System Validation (CSV) refers to a formal validation process applied to computerized
systems used in Research & Development environments. In regulated industries (governed by
frameworks like FDA 21 CFR Part 11, EU Annex 11, or GAMP 5), any software or computer system
that impacts product quality, patient safety, or data integrity must be formally validated before use.

Key Responsibilities
User Requirements Analysis - Reviewed and analyzed User Requirements Specifications (URS)
provided by the customer/stakeholder, ensuring requirements were complete, unambiguous, testable,
and aligned with intended system use and regulatory expectations

Functional Requirements Review & Refinement - Analyzed Functional Requirements Specifications
(FRS) against the URS to identify gaps, inconsistencies, or ambiguities; collaborated with development
and business teams to correct and refine requirements prior to validation execution

Installation Qualification (IQ) Test Case Development - Authored Installation Qualification protocols
and test cases to verify that the system is installed correctly, the environment meets defined
specifications, and all components are properly configured

Operational Qualification (OQ) Test Case Development - Designed and documented Operational

Qualification test cases to demonstrate that the system operates in accordance with functional
requirements across defined operating ranges and conditions

Validation Protocol Preparation — Prepared formal validation documentation including Validation
Plans, IQ/OQ/PQ protocols, Traceability Matrices, and Risk Assessments in compliance with
applicable QMS procedures and industry standards (GAMP 5, FDA 21 CFR Part 11, EU Annex 11)

Validation Test Execution - Executed validation protocols in a controlled manner, recording results,
deviations, and observations with full audit trail integrity; authored Validation Summary Reports upon
successful completion of testing

Project2:
The sub-system that is designed to provide reports as service for any client. Sub-system produces a set
of reports that have been crafted to help clinicians answer clinical questions about a patient.
The reports generated from this service are used to identify trends and track daily activities - such as
carbohydrates consumed, mealtimes, insulin delivery and glucose readings. The output is provided in
PDF format.

Key Responsibilities
- Leading test team
- Test Cases Development
- Test Execution
- Defect Reporting
- Functional Testing
- Regression Testing

Project3:
PI which allows access to the credit bureau information provides and makes a decision (credit approval
processes) based on the retrieved information.

Key Responsibilities

API testing
DB testing

Technologies

SQL, Postman, Fiddler, SQL client

Project4:
Medical devices are designed for use in blood centers and similar settings to assist with blood
donations. It monitors the flow of blood from the donor while automatically agitating the bag,
facilitating the mixing of blood and anticoagulants. The desktop app is data collection, management,
and device-programming interface that is used with medical devices. The desktop app is used to
configure and manage medical devices

Key Responsibilities

Mentoring trainee staff
Creating test plans and test reports
Embedded testing
Windows desktop app testing
Developed and execute test cases for functional testing of the application
Wrote bug reports and reported them via Jira.
Mobile testing
Web app testing
Requirements writing

Technologies

RTOS, Microchip, SQL, API, Jenkins, Git, iOS

Project4:
Web-based application created for booking VIP lodges and VIP seats at large stadiums. And for a pre-order meal
to lodges.

Key Responsibilities

Developed and execute test cases for functional testing of the application
Wrote easy-to-reproduce bug reports and reported them via Jira. Researched software defects to minimize the
number of steps to reproduce Check saving of user data in DB
Validated application’s UI according to requirements
Requirements analysis
Regression testing

Technologies

MS SQL, IE, Firefox, Opera, Safari, Chrome, Postman