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I am Nishanth Gandhi, a Software QA Manager with over a decade of experience shaping QA strategies for medical device software and Oracle E-Business applications. I have led cross-functional teams across offshore, onsite, and remote settings, delivering robust quality and regulatory compliant solutions. I excel at defining test strategies, building CI/CD pipelines (TeamCity), performing risk-based testing, and aligning QA activities with FDA/Health Canada ISO 13485 IEC 62304 standards. I enjoy mentoring teams and collaborating with product owners to release high-quality software on time and within budget.…I am Nishanth Gandhi, a Software QA Manager with over a decade of experience shaping QA strategies for medical device software and Oracle E-Business applications. I have led cross-functional teams across offshore, onsite, and remote settings, delivering robust quality and regulatory compliant solutions. I excel at defining test strategies, building CI/CD pipelines (TeamCity), performing risk-based testing, and aligning QA activities with FDA/Health Canada ISO 13485 IEC 62304 standards. I enjoy mentoring teams and collaborating with product owners to release high-quality software on time and within budget.

Nishanth Gandhi

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I am Nishanth Gandhi, a Software QA Manager with over a decade of experience shaping QA strategies for medical device software and Oracle E-Business applications. I have led cross-functional teams across offshore, onsite, and remote settings, delivering robust quality and regulatory compliant solutions. I excel at defining test strategies, building CI/CD pipelines (TeamCity), performing risk-based testing, and aligning QA activities with FDA/Health Canada ISO 13485 IEC 62304 standards. I enjoy mentoring teams and collaborating with product owners to release high-quality software on time and within budget.…I am Nishanth Gandhi, a Software QA Manager with over a decade of experience shaping QA strategies for medical device software and Oracle E-Business applications. I have led cross-functional teams across offshore, onsite, and remote settings, delivering robust quality and regulatory compliant solutions. I excel at defining test strategies, building CI/CD pipelines (TeamCity), performing risk-based testing, and aligning QA activities with FDA/Health Canada ISO 13485 IEC 62304 standards. I enjoy mentoring teams and collaborating with product owners to release high-quality software on time and within budget.

Available to hire

I am Nishanth Gandhi, a Software QA Manager with over a decade of experience shaping QA strategies for medical device software and Oracle E-Business applications. I have led cross-functional teams across offshore, onsite, and remote settings, delivering robust quality and regulatory compliant solutions.

I excel at defining test strategies, building CI/CD pipelines (TeamCity), performing risk-based testing, and aligning QA activities with FDA/Health Canada ISO 13485 IEC 62304 standards. I enjoy mentoring teams and collaborating with product owners to release high-quality software on time and within budget.

Skills

Experience Level

Expert

Expert

Expert

Expert

Work Experience

Software QA Manager at PulseMedica

January 1, 2024 - Present

Developed and implemented a comprehensive Software QA strategy aligned with regulatory and quality requirements. Collaborated with product owner, project manager and software manager to plan and deliver projects on time and on budget. Led, mentored, and coached the Software QA team, defined quality objectives and metrics. Created test strategies with automation applicable across software products and designed/tested plans to verify functionality, performance, and reliability. Performed manual, automated and integration testing on devices where applicable; participated in risk management for medical devices; ensured compliance with Health Canada, FDA, ISO 13485, IEC 62304. Prepared and maintained SQA documentation for regulatory submissions and audits. Selected and implemented QA tools and technologies and championed their adoption. Supported and executed projects to achieve strategic milestones.

Software QA Manager at Circle Cardiovascular Imaging

September 1, 2021 - May 1, 2024

Prepared test strategies and test planning based on project scope; planned resource allocation across multiple scrum teams; executed risk-based, priority-based test planning and execution. Implemented automation solutions and designed/maintained CI/CD pipelines with TeamCity. Managed releases, provided status reports to Directors/CTO, and hired/mentored new talent. Led performance testing initiatives and conducted weekly status meetings; investigated new tools and technologies to improve team efficiency. Designed and conducted manual and automated testing, including stress/load tests, and defined release readiness.

Software QA Lead at Circle Cardiovascular Imaging

February 1, 2020 - August 1, 2021

Designed, planned and executed test plans and cases from user requirements and functional design documents. Implemented performance testing across platforms and browsers and built/maintained automation test suites. Reported and tracked defects, performed cross-browser testing, and conducted knowledge transfer sessions. Conducted project reviews and provided post-go-live support. Prepared training materials and release artifacts (Traceability Matrix, Risk/Hazard matrices, Release Notes, Test Summary Reports).

Software QA Analyst at Circle Cardiovascular Imaging

August 1, 2016 - January 1, 2020

Performed testing of standalone and enterprise medical software applications. Executed functional, system, integration and regression testing on desktop and web platforms. Created and maintained test cases, verified requirements, and ensured fixed issues met expected outcomes. Collaborated with developers, maintained automated test suites, and troubleshot end-user issues with IT support. Provided knowledge transfer and contributed to QA documentation.

Senior Oracle Functional Consultant at Hitachi Consulting

January 1, 2015 - December 1, 2015

Collected and documented user requirements; participated in RFP analysis; translated requirements into business/functional specifications. Planned and executed testing, including backend validation using SQL Developer/TOAD. Designed test plans and test cases, performed cross-browser testing, and reported defects. Supported Oracle EBS modules and OBIEE reporting; managed Oracle EBS project deliverables and coordinated with DBA for performance and production issues. Conducted weekly client meetings, liaised with Oracle Support, and contributed to Lean project initiatives; trained end users; planned enhancements.

Oracle Functional Consultant at Genpact Pvt. Ltd

February 1, 2010 - January 1, 2015

Performed all setups for Purchasing, iProcurement, iSupplier, Inventory, and Order Management modules. Designed and documented functional specifications; conducted end-to-end SCM testing (AR, AP, OM, QP, BOM, INV, PO); assisted Business with UAT and obtained sign-off. Reported defects, coordinated with offshore and onsite teams, and provided knowledge transfer. Conducted pre/post project reviews and post-go-live support. Worked with Oracle Support on service requests, executed basic SQL queries, prepared training materials, developed HP QTP scripts for data conversion, and managed tests in HP Quality Center.