Position: QA Engineer
Category: QA
English level: fluent
Years of experience: 1.5

Detail oriented QA, applying knowledge of quality assurance testing to ensure the quality and safe operation of various parts and components.
Completed QA Manual course and trained on ISTQB Foundation level.
Proficient in manual testing, test case design and defect tracking. Committed to ensuring that quality standards are upheld to promote optimal customer satisfaction. Excellent communication and problem-solving skills with the ability to work collaboratively in a team environment.
Strong understanding of SDLC/STLC, software testing methodologies and principles, including manual testing, test planning, test case creation and defect tracking.
Experience in a Software Design Quality Engineer role in medical device industry, working closely with software engineering teams to ensure that the design control requirements are met. Skilled in all aspects of the Software Development Lifecycle Process as it pertains to design controls from Concept to Design Transfer, as well as for the risk management process as it pertains to the design changes for the software modules/features. Able to perform meaningful reviews and propose changes to ensure compliance with regulatory requirements, i.e. ISO 13485 and IEC 62304 standards, as well as with the GDP (good documentation practice).
Over the course of my career as a Design Quality Engineer, I have gained much experience in reviewing design verification artifacts (test designs, test plans, test results and test reports; traces from requirements to functional verification test results), as well as performing impact assessments for design, process, and risk control activities as required. And I am confident that my previous experience as a DQE will help me take on a new role of a Manual QA in a dynamic project that fosters growth and learning opportunities.
GlobalLogic, Ukraine, Kyiv
DQA (Design Quality Assurance), Software Design Quality Engineer
(October 2021 - Present time)
The project belongs to a world-leading medical device manufacturer and deals with software development for the minimally-invasive Robotically-Assisted Surgery system (class C medical device software):
- collaborating with the assigned Project team which includes but is not limited to Project Managers, Software developers and Software testers.
- responsible for design deliverables review for the assigned Project including but not limited to Software requirements, Design documents, Test plans, Test reports, Trace matrix to ensure design control requirements are met.
- acting as a software design quality advocate throughout the software development life cycle for the Project.
- responsible for the design changes review for the assigned Project and creating failure modes and performing hazard analysis, as applicable.
- maintaining the software failure mode & effects analysis (sFMEA).
- performing reviews during Software development life cycle process as it pertains to requirements reviews, test case reviews and test results reviews, including objective evidence.
- work with software configuration management as it pertains to the software test and production environments.
- ensuring that the Software team is following the software development lifecycle process as documented in the internal company's procedures and in compliance with IEC 62304 and ISO 13485 for design controls.

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