Mariya Francis
Thrissur,India
Summary
Accomplished professional with expertise in ALM, manual testing, and biomedical device testing. Demonstrates proficiency in MS Office Suite, MATLAB, and validation protocols to ensure compliance with EU MDR and FDA standards. Skilled in clinical research support, quality assurance, and documentation, with a focus on risk assessment and post-market surveillance. Committed to advancing career goals in compliance and quality assurance within the biomedical sector.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
Work history
Validation & Verification Tester - Medical Imaging Solutions
Capgemini Technology Services India Ltd.
07.2022 - 07.2024
- Executed end-to-end testing for medical imaging products (Solution VNV, Centricity PACS, Cloud Solution VNV).
- Conducted installation, upgrades, and workflow integration in both on-premise and cloud environments.
- Performed risk-based testing and defect tracking to ensure adherence to FDA 21 CFR Part 11 and EU MDR guidelines.
- Developed test cases and documented validation processes in ALM for medical applications.
- Performed manual testing, logged defects, and collaborated with developers for resolution.
- Proposed usability and functionality improvements, enhancing product performance and regulatory compliance.
Intern
Industrus Tech
05.2020 - 05.2020
- Delivered comprehensive training in medical coding, covering essential concepts and practices.
- Developed instructional materials to enhance learning outcomes for participants.
- Facilitated interactive workshops, promoting engagement and practical application of coding skills.
Intern
Cyrix Healthcare Pvt Ltd
06.2019 - 07.2019
- Conducted practical training sessions on ICU equipment operation and maintenance.
- Delivered hands-on learning experiences in critical care technologies.
- Facilitated skill development for healthcare professionals in ICU settings.
Education
Masters - Medical Device Regulatory affairs
SOUTH EAST TECHNOLOGICAL UNIVERSITY
09.2024 - 09.2025
Bachelors - Biomedical Engineering
SAHRDAYA COLLEGE OF ENGINEERING AND TECHNOLOGY
08.2018 - 06.2022
Class XII - BioMaths
BHARATIYA VIDYA BHAVAN'S VIDYA MANDIR POOCHATTY,THRISSUR (CBSE)
Thrissur, India 06.2017 - 03.2018
Class X -
BHARATIYA VIDYA BHAVAN'S VIDYA MANDIR POOCHATTY,THRISSUR (CBSE)
Thrissur, India 06.2015 - 03.2016
Skills
- ALM
- Manual Testing
- MS Office Suite
- MATLAB
- Validation Protocols
- Test Scripts
- Defect tracking
- EU MDR
- FDA
- Clinical Research Support
- Quality Assurance
- Documentation
- Risk Assessment
- Compliance
- Biomedical Device Testing
- Post-Market Surveillance
Languages
English
Upper intermediate
Malayalam
Native
Hindi
Elementary
CERTIFICATES & WORKSHOPS
- Introduction to Internet of Things, NPTEL, Elite Certificate
- Arduino, IEEE Workshops
- MATLAB, IEEE Workshops
- PCB Design, IEEE Workshops
- Web Development, IEEE Workshops
- Ventilator Design Perspectives, Webinar
- IEEE IEDC Summit Volunteer, Webinar
Timeline
Masters - Medical Device Regulatory affairs
SOUTH EAST TECHNOLOGICAL UNIVERSITY
09.2024 - 09.2025
Validation & Verification Tester - Medical Imaging Solutions
Capgemini Technology Services India Ltd.
07.2022 - 07.2024
Intern
Industrus Tech
05.2020 - 05.2020
Intern
Cyrix Healthcare Pvt Ltd
06.2019 - 07.2019
Bachelors - Biomedical Engineering
SAHRDAYA COLLEGE OF ENGINEERING AND TECHNOLOGY
08.2018 - 06.2022
Class XII - BioMaths
BHARATIYA VIDYA BHAVAN'S VIDYA MANDIR POOCHATTY,THRISSUR (CBSE)
06.2017 - 03.2018
Class X -
BHARATIYA VIDYA BHAVAN'S VIDYA MANDIR POOCHATTY,THRISSUR (CBSE)
06.2015 - 03.2016
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