ISTQB certified QA tester

Jolly Vaidya LinkedIn: https://www.linkedin.com/in/jolly-vaidya-51059831

Ph: 321-***-**** **********@*****.*** Garner, NC 27529

Professional Summary

Quality-focused professional with 4.5+ years of progressive experience in software & hardware testing within medical devices as well as healthcare environments.

Proven ability to manage QA processes across the SDLC, including verification, validation, CAPA, risk management, and regulatory compliance (GMP, FDA, ISO 13485).

Adept in Agile and Waterfall methodologies, with hands-on testing and documentation experience supporting FDA/EU-compliant products.

Collaborative team player with a continuous improvement mindset and a strong command of QA tools like Jira, Confluence, and Postman.

Core Competencies

Quality & Compliance

Good Manufacturing Practices (GMP)

FDA 21 CFR Part 11 Compliance, ISO 13485 / ISO 9001 Standards

CAPA / Root Cause Analysis, Deviation & Change Control Management

Risk Assessment & Mitigation

Product Disposition & Batch Review

Tools & Technical Skills

Postman (API Testing), Jira, Confluence (Agile Project Management)

Tableau (QA Analytics & KPIs), Office 365 Suite (Excel, Word, PowerPoint, Outlook)

PowerShell, Python, MySQL, AWS, WinSCP, Console

Testing & Documentation

IQ/OQ/PQ Protocol Development & Execution, SOP & Protocol Development

Integration, Regression, UAT & Automated Testing, SDLC / Agile / Waterfall, CI/CD Process Support

Soft Skills

Detail-Oriented & Analytical, Excellent Written & Verbal Communication

Cross-Functional Collaboration, Adaptability in Regulated Environments

Fast Learner, Strong Work Ethic, Task Prioritization & Multi-Tasking

Certifications

The complete GMP Course certified Apr 2025

Certified Tester Foundation Level (ISTQB) Apr 2025

Link> https://atsqa.org/certified-testers/profile/e0f8dc3887e3498cb7bc9352c6dbd68f

Certified PCEP-Python Programmer Link> https://pythoninstitute.org/pcep Jan 2024

Certified IT Specialist Python Link> https://certiport.pearsonvue.com/fc/ITS/python Dec2023

Certified IT Specialist Databases Link> https://certiport.pearsonvue.com/fc/ITS/database Oct 2023

Professional Experience

Sr. Product QA Tester Spencer Health Solutions, NC Feb 2023 – Feb 2025

Contributed to quality assurance efforts for FDA and EU-compliant medical device dispensing systems as a team member

Developed and executed test plans for software and hardware across full SDLC.

Conducted root cause investigations, managed CAPA documentation and follow-ups.

Participated in risk assessments, change control, and document reviews.

Collaborated across engineering, hardware, and software teams for QA improvements.

Conducted internal audit preparations and supported QMS initiatives.

Supported product disposition reviews, batch analysis, and system monitoring.

Ensured compliance with GMP, HIPAA, GDPR and ISO 13485 through documentation and process adherence.

Actively used Jira, Confluence, Tableau, and Postman for test tracking, analysis, and reporting.

Product Quality Technician Spencer Health Solutions, NC Oct 2022 – Jan 2023

Performed regression and device testing to verify production readiness.

Executed IQ/OQ procedures for quality control of medical devices.

Participated in audit support, supplier input evaluations, and risk register updates.

Tracked and reported non-conformances and participated in change control procedures.

Contributed to product release readiness by ensuring completion of required quality checks.

Collaborated on updating inspection procedures and SOPs to align with GMP standards.

Communicated workload progress, prioritized tasks efficiently in Agile sprints.

Contributed to continuous improvement initiatives and lean process refinements.

QA Testing Associate Almighty LLC Mar 2020 – Apr 2022

Conducted vulnerability assessments and supported remediation team through QA reports.

Analyzed Power BI dashboards for gaps and created end-user reports for leadership.

Pre-Go-Live QA testing documentation of software for enterprise clients.

Software Tester Tornado Software Pvt. Ltd. 2015 – 2019

Conducted user acceptance testing (UAT) and gathered end-user feedback for bug resolution.

Executed load, stress, and scalability testing; collaborated with developers to improve system performance.

Education

Bachelor of Commerce (B. Com) Gujarat University, India

Major: Advanced Accounting and Auditing

Languages (Fluent Written and Spoken)

English, Hindi, Gujarati

Additional Interests

Certified Graduate in Bharatanatyam (Indian Classical Dance)

Vastu Shastra & Jyotish Acharya Studies

Volunteer: Divine Aura Healing Foundation

Former President, Parents Association – Shreyas Foundation School

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