Quality Assurance Medical Device

Manan Shah

331-***-**** *****.********@*****.*** LinkedIn Profile: www.linkedin.com/in/max20

SUMMARY

Highly experienced and results-driven Quality Assurance Architect with a proven track record in leading and executing comprehensive testing strategies within the medical device and healthcare industries. Expertise in backend, integration, manual, and automated testing methodologies, coupled with strong leadership skills in managing cross-functional teams and driving quality initiatives. Proficient in navigating regulatory requirements (e.g., FDA) and ensuring product compliance. Adept at integrating AI and ML technologies into QA processes to improve efficiency and accuracy. Focused on delivering high-quality, reliable solutions that meet and exceed industry standards.

SKILLS

QA Methodologies: Agile (Scrum, Kanban), Waterfall, Hybrid

Test Management: Jira, Azure DevOps, Rally, HP ALM/QC (Quality Center), TestRail

Automation Tools: Appium, Selenium, LeanFT (UFT One), JUnit, TestNG, Cypress, Postman, RestAssured

Backend Testing: API Testing (REST, SOAP), Database Testing (SQL, Oracle), Microservices Testing

Integration Testing: System Integration Testing (SIT), End-to-End Testing (E2E)

Mobile Testing: iOS, Android

Performance Testing: JMeter, LoadRunner

Security Testing: OWASP, Static/Dynamic Analysis Tools

Cloud Technologies: AWS, Azure

Databases: Oracle, SQL Server

Operating Systems: Windows, macOS, Linux

Programming Languages: Java, C#, Python

Project Management: Monday.com, Slack, MS Project

Data Analysis & Visualization: Qlik, Tableau

Regulatory Compliance: FDA Regulations (21 CFR Part 11), HIPAA

EXPERIENCE

Navistar (International, INC), Lisle, IL

Lead QA Engineer – Manhattan WMS Implementation March 2024 – April 2025

Led the QA strategy and execution for the enterprise-wide migration from a legacy warehouse management system to Manhattan Active Warehouse Management (MAWM).

Directed cross-functional QA activities involving test planning, manual validation, and offshore coordination to ensure successful system rollout and post-go-live support.

Created and managed scalable test scripts using ADO and backend scripts using SQL server.

Oversaw test case design and execution for warehouse operations: inbound receiving, RF picking, wave management, labor tracking, and outbound logistics.

Delivered backend validation using complex SQL queries to verify inventory accuracy, transaction histories, and data flows across integrated systems.

Conducted performance and load testing of critical WMS functions to validate system scalability and response under volume stress.

Worked closely with 3rd-party vendors and offshore QA teams, ensuring alignment on requirements, quality metrics, and defect triage SLAs.

Provided clear, executive-level reporting and presented QA readiness updates to leadership and key stakeholders, focusing on risk, test coverage, and release confidence.

Used ADO and ALM to manage the full test lifecycle, from requirement traceability to defect closure and release notes.

Championed best practices in test data management, UAT coordination, and regression planning, ensuring smooth transition from legacy systems to MAWM.

Medtronic, Mounds View, MN

QA Manager August 2019 – March 2024

Led and mentored a team of QA engineers (onshore/offshore) in mobile application testing for medical device software, ensuring adherence to FDA regulations and industry best practices.

Developed and implemented comprehensive testing strategies for iOS applications using both manual and automated techniques.

Managed test execution, defect tracking, and reporting using Jira and Zephyr, with a strong focus on exploratory testing.

Spearheaded automation with Appium and Java (TestNG), reducing manual efforts by 30%.

Conducted code reviews, performed CI/CT using Jenkins, and maintained repositories via Bitbucket.

Supported manual testing for critical code areas and developed test scripts for manual testers.

Managed sprint planning, team communication (Slack), and team performance monitoring.

Implemented performance testing using JMeter and manual load simulations.

Conducted OWASP-based security testing and manual logic flaw detection.

Applause, Remote

Testing Services Manager November 2015 – October 2023

Oversaw QA for AI/ML-driven projects including human interaction and facial detection applications.

Managed global QA projects ($2.5M+) across cloud, finance, and legal domains.

Built and led teams of 30+ test engineers and 100+ test leads.

Balanced automated/manual strategies and trained teams in both disciplines.

Validated AI outputs manually and tested across devices using Sauce Labs and BrowserStack.

Used Jira, Confluence, Azure DevOps for project and test management.

Delivered metrics and executive dashboards using Tableau and Qlik.

GE Healthcare, Milwaukee, WI

Validation Architect Lead / Offshore Lead October 2016 – July 2019

Led validation of CardioLab and Mac-Lab systems in compliance with FDA and regulatory standards.

Developed validation strategies using HP ALM, Rational DOORS, and LeanFT.

Oversaw test planning and traceability; documented validation results in SharePoint.

Performed manual/automated black-box testing and sign-off procedures.

Managed offshore teams using Agile methods with Rally.

RR Donnelley, Warrenville, IL

Automation Architect / Offshore Lead December 2015 – October 2016

Apollo Education, Warrenville, IL

Automation Architect QA / Integration Test Lead July 2014 – December 2015

Capital One, Richmond, VA, and Chicago, IL

Integration Test Lead / Automation Lead August 2012 – July 2014

EDUCATION

Westminster College of Computing – Postgraduate Degree in Information Technology 2007

University of Wales Institute Cardiff – Master’s Degree in Business Administration 2006

Gujarat University – Bachelor’s Degree in Commerce 2002

CERTIFICATIONS

MCSD MCDBA A+ Certified Oracle 8 DBA DIT (Diploma in Information Technology)

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