# Archana Nagaraja

> Software Testing | Verification & Validation | Medical Device Software R&D| Mobile/web  app testing | FDA and ISO regulated environment | CSM Certified | freelancer | Web design/devlopment

Location: San Francisco Bay Area, United States
Profile: https://flows.cv/archana

- 10+ years of Software Testing experience delivering high quality medical products, mobile and web applications.
- Strong working knowledge in quality software engineering processes in compliance with ISO, FDA standards including 510(k) clearance.
- Knowledge in medical Standards: ISO 14971, ISO 13485
Compliance: FDA 21 CFR Part 11, FDA 21 CFR Part 820,  IEC 62304
- Hands on testing experience of medical products in Embedded C, C++
- Expertise in embedded systems testing, including unit testing, integration testing, functional testing and system level validation of both software and hardware components.
- Experience in developing robust project documentation including test plans, test protocols, test cases (manual and automated), bug reports, test summaries/reports and statistical reports using good documentation practices(GDP)
- Involved in Dry Run and Formal Run of test protocols. Involved in smoke and sanity testing of various versions of the software.
- Experience in building QA teams from scratch, coordinating and scheduling work of team members, leading QA team in startup companies.
- Experience in deploying and providing support of Cerner product suite at various hospitals.
- Experience in developing SQL queries for backend database testing.
- Experience with Scrum/Agile software development methodologies.
- Working knowledge of software test management software (HP Quality Center), Requirements Management software(DOORS), and Defect Tracking software (JIRA)
- Performed End-to-End web testing, including cross browser testing of the application.
- Have generated test data for simulating different scenarios such as positive, negative, class equivalency and boundary tests.
- Have automated and maintained the test stubs using Java on Appium for both iOS and Android apps.
- Crash Log Analysis using Xcode, logcat, ADB commands, testing the apps against App Store and Google Play Rejection Criteria.
- Creating JSON files for Feed testing & Web service testing.
- Testing In-App Purchase and Push Notification on iOS & Android Application.
- Good knowledge in programming - Core Java, Python, HTML, CSS, JS. 
- Well versed in both Windows and Linux platforms.
- Proven leadership and teamwork, mentoring new team members, critical thinking and problem solving.
- Excellent written and oral communication, fast learner.

## Work Experience
### Senior Software Test Engineer - Design/ Product Development (R&D) @ Abbott
Jan 2022 – Present | Alameda, California, United States

### Freelance Web Developer @ Unknown
Jan 2021 – Jan 2022
Helped an NGO group to set up their website, handled their website content using html, css and Wordpress.

### Software Test Engineer - Verification (R&D) @ Abbott
Jan 2020 – Jan 2021 | Santa Clara, California, United States
Project :  FDA program - 510k Submission/Clearance for US market launch of the Abbott Alinity h-series
Description: As an integral member of Abbott Hematology’s Software Engineering R & D team, my role involved supporting the software verification process of medical device software. Also, support development software releases by performing acceptance testing, logging defects, and providing recommendations on build readiness. Working in the lab on medical devices with robotics technology, barcode reader, real specimen samples as well as simulators to test actual instrumentation for software defects. This role can highly impact identification and treatment for hematology patients by implementing products in hospitals and laboratories.  
Responsibilities:
- Work with the requirements team to understand business needs - Familiar with ALM tools - Doors, Helix, Rational
- Work with test leads and software developers to ensure quality processes are integrated throughout an iterative and fast-paced development agile environment. 
- Write test protocols from technical designs, specifications, and requirements. Review/approve teams test protocols. Familiar with tools like HP Quality Center 
- Dry run, approve & execute software verification test protocols for manual and automated test cases. Create detailed and optimized test designs for software features and functions. Review and approve team's formal test runs. 
- Perform smoke, integration, acceptance, regression and stress tests on the software releases, perform NPV-non product verification for simulators used for testing. Configure basic switches and routers connections as part of testing, analyze system logs and reports as part of debugging. Familiar with working in QNX and Linux environments.
- Maintain traceability of requirements to protocols.

- Isolate, characterize & log new software defects with detailed defect reports.Verify & close resolved software defects. Familiar with Jira, SBM defect tracking tools

### QA Lead @ 75F
Jan 2016 – Jan 2018 | Bengaluru Area, India
Responsibilities include:
- Build, manage, mentor and inspire a high performance Quality Engineering team 
- Execute test plans and create test reports to describe program evaluation, testing, and correction
- Worked towards introducing automated CI/CD process into the system using Jenkins
- Assist Application Developers and technical support staff in identifying and resolving problems
- Recommend design improvements or corrections to engineers throughout the development process
- Work closely with the development team and come up with unit tests after each commit 
- Deliver quality assured user stories/bugs on time at the end of every sprint
- Brainstorm with the product owner and come up with a detailed use cases for the user stories. Provide product information as a quality person while designing user stories
- Write technical documents for the marketing team for their client presentations and for the website
- Defect logging and defect verification

### Sr QA Engineer @ Atimi Software
Jan 2013 – Jan 2015 | Bengaluru Area, India
Responsibilities include:
- Develop, review and maintain use cases, end to end test scenarios, test cases and regression tests
- Automate and maintain the test scripts using Appium for both iOS and Android apps
- Creating various Testing Metrics in the various status reports like Weekly Status Reports, Monthly Dashboard and Test Summary Reports
- Crash Log Analysis using Xcode
- Testing the App against App Store and Google Play Rejection Criteria
- Debugging and troubleshooting iPhone/iPad applications using Xcode
- Creating JSON files for Feed testing & Web service testing
- Testing In-App Purchase and Push Notification on iOS & Android Application
- A/B Testing (Optimization Testing), Requirement Analysis, Defect Logging and Tracking
- Functional and Regression Testing
- Communicate risks and issues identified during testing activities

### Sr. QA Engineer @ Cerner Corporation
Jan 2006 – Jan 2011 | Bengaluru Area, India
Cerner is a leading provider of digital information systems used within hospitals and health systems to enable medical professionals to deliver better healthcare to individual patients and communities.

Responsibilities include:
- Understanding the software specs/user stories, deriving, executing and maintaining the test cases
- Performing various kinds of testing which include Functional testing, GUI testing, Sanity testing, Network, Regression testing, Adhoc testing, performance testing and Localization testing
- Logging bugs, tracking them, verify fixed defects and take them to closure, generate status reports, collecting metrics and taking corrective actions
- Code coverage using Rational Pure Coverage Tool identifying the gaps in the test case suite.
- Mentoring the team, Client interaction, assist clients onboard to our products
- Client appreciation during the ACE program - go live at Carolinas Medical Center, Charlotte, NC while assisting them on-board our products


## Education
### Full Stack Web Development Bootcamp
University of California, Berkeley

### B.E in Electronics and Communications
Visvesvaraya Technological University


## Contact & Social
- LinkedIn: https://linkedin.com/in/archana-nagaraja

---
Source: https://flows.cv/archana
JSON Resume: https://flows.cv/archana/resume.json
Last updated: 2026-03-29