Jayeeta Saha
Perth,WA
Summary
A Lead Quality Assurance/Quality Engineer with 8+ years of experience in New Product Development, Sustenance, Gap Assessment and Remediation, within the Healthcare, Lifesciences and Medical Equipment Manufacturing industries.
Brief Experience: Performed a wide variety of activities pertaining to compliance with applicable regulatory requirements (ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820, 21 CFR Part 11, EU MDR), Software Risk management, Quality Management System (QMS) maintenance, improvement and harmonization, and Quality Control and Assurance. Accountable for oversight of quality and risk management throughout the Software Development Lifecycle. Review and Approval of designated project documentation in product creation projects. Advice to product creation projects concerning the definition and implementation of Quality Assurance activities. Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments. Initiate, stimulate, and support the implementation of process improvements.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Development QA/ QE Officer
Philips India Limited
07.2021 - 04.2024
- Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management
- Review and Approval of designated project documentation in product creation projects
- Advice to product creation projects concerning the definition and implementation of quality assurance activities
- Advise upper management with respect to release for delivery of products
- Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
- Initiate, stimulate, and support the implementation of process improvements
- Execution of audits in all business processes and report the findings to upper management
- Support and advise the organization in corrective and preventive actions
Software Quality Assurance / Computer System Validation (CSV) Engineer
Tata Consultancy Services Limited
11.2015 - 06.2021
- Software Validation of Phaco-Cataract Surgery devices, and medical device software in accordance with requirements from IEC 62304, ISO13485, ISO 14971, 21 CFR Part 820 and FDA General Principal for Software Validation
- Development of SDLC Planning records such as - Software Development Plan (SDP), Software Risk Management Plan, Remediation Plan
- Review of Product, System, and Software Requirement Specifications, Software Architecture Design, and Software Detailed Design
- Performed Risk Analysis following FMEA Method and develop risk control measures
- Review of Test Plan and Protocols for Unit, Integration, System and Acceptance Testing and respective Test Execution and Test Summary Reports
- Review of Software Traceability Matrices
- End to End Gap assessment and Remediation activities for Quality Management System (QMS) Software including modules like Non-Conformance, (NC), Corrective and Preventive Action (CAPA), Global Change Control (GCC) etc
- Review of Performance Qualification records
- Traceability Analysis and Review of Requirement Traceability Matrices
- CAPA closure report
- Risked based Validation of PLC and HMI Control Systems` for Automated Contact Lens Manufacturing components (using cGMP, GAMP4 and GAMP5) and non- product software
- Performed Regulatory Gap Assessment and Remediation activities in accordance with 21 CFR Part 11 and QSIT checklist
- Review of Information Guides, Technical Resource Manuals
- Team Lead for 10 team members working from multi-locations
- Agile Project Management activities including Resource Management, Billing Management, Leave Tracking, Process Improvement (PDCA)
Guest Assistant Professor
Bengal Institute Of Technology
07.2013 - 10.2015
- Lectureship in Electronics and Telecommunication Engineering
- Final year project supervisor
Test Engineer
Bhargab Engineering Works
03.2011 - 12.2012
- Code Review in ALLEN BRADLEY, MESSUNG and MITSUBISHI PLC Platforms for Automation of Several Tea Cleaning and Blending Machine
- Design Review of Control Panel
- Developed / Reviewed Test Plan, Test Protocol
- Test Scenarios and Test Scripts
- Performed Unit / Integration / System/ Acceptance and Regression Testing
- Developed and Reviewed Test Execution and Test Summary Reports
- Identified, analyzed, and logged defects, and performed debugging in compliance with software problem resolution process
Education
M.Tech - Intelligent Automation and Robotics (Electronics and Telecommunication Engineering)
Jadavpur University
06.2015
B.Tech - Electronics and Instrumentation Engineering
Netaji Subhash Engineering College
06.2011
Skills
- Quality Assurance
- Engineering for New Product Development
- Computer System Validation (CSV)
- Regulatory Gap Assessment and Remediation
- Risk Assessment
- Software Development and Validation Planning
- Creation of Software Requirement Analysis
- Review and Finalization of Software Architecture and Detailed Design
- System Acceptance and Regression Test Planning
- Creation of Test Plan, Test Script and Test Report
- Test Report Defect Logging and Tracking till closure
- Software Requirement Traceability Analysis
- Machine Learning model development using R and Python
- Signal Processing using Python
- Artificial Intelligence
- IOT
- Programming using MATLAB
- Ladder Logic Programming (Allen Bradley, Mitsubishi, Messung PLC)
- Programming for Human Machine Interface (Mitsubishi)
- Microprocessor 8085 Programming
Certification
- ASCENT- The Foundation for your Leadership Journey - Business English Certification
- Introduction to Quality System Regulations Foundation
- BDA : Certificate in Medical Devices
- Introduction to Diagnostic Devices Foundation
- FDA regulation 21 CFR Part 820 Intermediate
- Basics of Medical Devices Foundation
- Medical Device Classification Foundation
- Software Development standard for Medical Devices
- Introduction to medical device regulatory standards Foundation
Accomplishments
- Paper and Patent, Title: Video Artifact removal and video restoration Inventor name(s): Jayeeta Saha, Karthik Seemakurthy, Jayavardhana Rama GubbiLakshminarasimha, Vartika Sengar, Aparna Kanakatte Gurumurthy, Avik Ghose, Balamuralidhar Purushothaman, Murali Poduval, Srinivasan Jayaraman Invention Origination Jurisdiction: India Suggested File Jurisdiction: India Disclosure Date: 05-Nov-2020 IDF- 1027729-056
- Saha, Jayeeta, Arnab Kumar Saha, Aiswarya Chatterjee, Suyash Agrawal, Ankita Saha, Avirup Kar, and Himadri Nath Saha. "Advanced IOT based combined remote health monitoring, home automation and alarm system." In 2018 IEEE 8th Annual Computing and Communication Workshop and Conference (CCWC), pp. 602-606. IEEE, 2018.
- Saha, Arnab Kumar, Jayeeta Saha, Radhika Ray, Sachet Sircar, Subhojit Dutta, Soummyo Priyo Chattopadhyay, and Himadri Nath Saha. "IOT-based drone for improvement of crop quality in agricultural field." In 2018 IEEE 8th Annual Computing and Communication Workshop and Conference (CCWC), pp. 612-615. IEEE, 2018.
- Surgical Smoke Dehazing and color Reconstruction (IEEE International Symposium on Biomedical Imaging (ISBI) (ISBI 2021)
- Realtime Robust Estimatiom of Breathing Rate from PPG using commercial grade Smart Devices (accepted in SenSys 2020); Author: Vivek Chandel, Jayeeta Saha, Chirayata Bhattacharyya, Avik Ghosh
Regulatoryframework
- ISO 13485
- IEC 62304
- ISO 14971
- ISO 9001
- 21 CFR Parts 803, 806, and 820
- 21 CFR Part 11
- GAMP4
- GAMP5
- CGMP
- IEC 62366
- EU MDR
Languages
- English
- Bengali
- Hindi
- Deutsche
Awards
- Received "On the Spot Award" received four times throughout TCS career.
- Received "Service and Commitment Award" twice throughout TCS career.
- Received "Star of the Month Award" from TCS.
- Received "Star Team Award" from TCS.
Languages
English
Professional
Bengali
Professional
Hindi
Professional
German
Limited
Tools
- Windchill
- AGILE
- ClearQuest
- QUMAS
- Team Center
- ETQ Reliance (VIBES)
Timeline
Development QA/ QE Officer
Philips India Limited
07.2021 - 04.2024
Software Quality Assurance / Computer System Validation (CSV) Engineer
Tata Consultancy Services Limited
11.2015 - 06.2021
Guest Assistant Professor
Bengal Institute Of Technology
07.2013 - 10.2015
Test Engineer
Bhargab Engineering Works
03.2011 - 12.2012
M.Tech - Intelligent Automation and Robotics (Electronics and Telecommunication Engineering)
Jadavpur University
B.Tech - Electronics and Instrumentation Engineering
Netaji Subhash Engineering College
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