Pranali Kubal
Lead Engineer (DQA) | MSc Process Validation & Regulatory Affairs Student at TUS Ireland | 9+ Years Medical Device Expertise
- Role
- Lead Engineer - Design Quality Assurance at HCLTech
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pranali Kubal
I am a Quality & Regulatory professional with over 9 years of experience in the Medical Device industry, currently transitioning to Ireland to pursue an MSc in Process Validation and Regulatory Affairs at the Technological University of the Shannon (TUS).Throughout my career at global organizations like Tata Elxsi and HCL Technologies, I have specialized in ensuring compliance with international standards (ISO 13485, EU MDR, US FDA). My expertise lies in navigating complex regulatory landscapes, managing quality management systems (QMS), and leading engineering teams to deliver high-standard healthcare solutions.Key Expertise:Regulatory Compliance: EU MDR, FDA 21 CFR Part 820, ISO 14971 (Risk Management).Quality Assurance: Internal Audits, Gap Analysis, and CAPA Management.Process Validation: Specialized interest in streamlining manufacturing and software validation protocols.Leadership: Managing cross-functional teams and stakeholder communication.As I move into the Irish MedTech ecosystem—one of the most vibrant healthcare hubs in the world—I am eager to connect with professionals in the Regulatory and Quality space. I am passionate about continuous learning, process excellence, and the impact of safe medical technology on patient lives.Outside of work, I am an enthusiast of gardening, cooking, and exploring local cultures. I find that a balanced perspective and a quiet, focused environment are the keys to professional excellence.Let’s connect to discuss RA/QA trends, Process Validation, or life in the Irish MedTech sector!
Experience
Lead Engineer - Design Quality Assurance
Feb 2022 — Present · Chennai, IN
Technical lead Engineer|Regulatory Affairs|Clinical Analyst|Design Assurance
Education
Vidyalankar Institute of Technology
Bachelor of Engineering (BE), Biomedical/Medical Engineering
2012 — 2015
V.P.M's Polytechnic
Diploma, Medical Electronics
2009 — 2012
Skills
- Performance Testing
- X-Ray
- Microsoft Office
- Sales
- Manual Testing
- C
- Powerpoint
- Field Service
- Leadership
- Functional Testing
- Healthcare
- Microsoft Word
- Teamwork
- Test Automation
- Matlab
- Medical Devices
- Marketing
- Biomedical Engineering
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