Associate Quality Engineer

Job Summary

The Associate Quality Engineer supports software quality assurance, software testing, verification and validation (V&V), and compliance activities in a regulated environment. This entry-level role assists with reviewing software requirements and deliverables, developing and executing test documentation, supporting defect management, maintaining traceability, and participating in software lifecycle quality activities. The position works under the guidance of senior Software Quality and Quality Assurance team members and collaborates with cross-functional teams including Software/R&D, Quality Assurance, and Regulatory Affairs. The ideal candidate has a foundation in software testing, application and API testing, defect tracking, and software development lifecycle processes, with an interest in developing expertise in regulated software and medical device quality systems.

Work mode: 2 WFH, 3 WHO Location: Bengaluru

Principal Duties and Responsibilities:

Support software quality assurance activities throughout the software development lifecycle (SDLC).

Assist with software verification and validation (V&V) activities, including development, review, execution, and documentation of test plans, test cases, test protocols, and test reports.

Perform functional, integration, system, regression, and exploratory testing for software applications, including embedded, desktop, web-based, and cloud-based systems, as applicable.

Support application testing to identify functional defects, UI issues, usability concerns, performance issues, and inconsistencies.

Execute and document testing of software features and verify defect corrections and implemented fixes.

Support the review of software requirements, design documentation, test documentation, and other software deliverables for completeness, clarity, consistency, and testability.

Participate in requirements activities and assist with ensuring requirements are clear, complete, traceable, and verifiable.

Assist with maintaining traceability between software requirements, risk controls, test cases, and verification evidence using Requirements Traceability Matrices (RTMs) or similar tools.

Support defect tracking, investigation, documentation, retesting, and closure activities.

Assist with testing REST APIs and software interfaces, including validation of requests, responses, error handling, and status codes using tools such as Postman and Swagger/OpenAPI.

Support software integration testing between frontend, backend, databases, and external interfaces.

Assist with software change management activities, including impact assessments, regression testing, and updates to applicable documentation.

Assist with maintaining configuration and release traceability and supporting software version and change documentation.

Prepare and maintain validation and quality documentation, including test plans, protocols, test cases, execution records, RTMs, validation reports, and other objective evidence.

Support compliance with applicable quality system procedures and regulatory requirements, including FDA regulations, IEC 62304, ISO 13485, ISO 14971, GAMP 5, and 21 CFR Part 11, as applicable.

Assist with audit readiness activities and provide documentation or support during internal audits, external audits, and regulatory inspections as needed.

Collaborate effectively with R&D, Software Engineering, QA, and Regulatory teams to support software quality objectives.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence (i.e., knowledge, skills and abilities)

Familiarity with web and application testing, including identification of UI defects, functional errors, formatting inconsistencies, responsiveness, and overall software quality issues.

Exposure to REST API development and testing, including API requests and responses, HTTP methods and status codes, CRUD operations, and tools such as Postman and Swagger/OpenAPI.

Exposure to Python and backend frameworks such as Flask and/or Django, with basic understanding of frontend-to-backend integration, software debugging, and relational databases such as MySQL and/or MariaDB.

Basic understanding of software quality processes, the Software Development Lifecycle (SDLC), software verification and validation (V&V), configuration management, version control, and software release traceability.

Familiarity with regulatory and quality concepts and standards applicable to software, including FDA regulations, IEC 62304, ISO 13485, ISO 14971, GAMP 5, and 21 CFR Part 11, as well as risk management, change management, and documentation control processes.

Strong analytical, problem-solving, organization, communication, and attention-to-detail skills, with the ability to document issues, test results, and findings clearly, work independently under guidance, and collaborate effectively in a cross-functional team environment.

Education/Experience Requirements

Bachelor’s degree in computer science, Computer Engineering, Software Engineering, Information Technology, or a related technical field required.

0–2 years of experience in software testing, software quality assurance, software validation, software development, or a related technical role.

Internship, co-op, academic project, or equivalent hands-on experience in software testing, application development, API development/testing, or software quality is strongly preferred.

Experience identifying and documenting software defects and verifying implemented fixes is preferred.

Exposure to REST APIs, Python, Flask, Django, Postman, Swagger/OpenAPI, MySQL, MariaDB, or similar technologies is preferred.

Experience or exposure to regulated industries, including medical device, healthcare, life sciences, or other regulated environments, is a plus.

Experience working with cross-functional teams, including Software/R&D, QA, and Regulatory, is preferred.

EOE/M/F/Vet/Disability