Jacob Mathew

About Jacob Mathew

Seasoned Software Quality Assurance professional with a robust background in regulated sectors such as Medical Device and Pharmaceutical manufacturing. Proven ability to lead QA teams, manage process implementation, and oversee both onshore and offshore resources. Experienced in ISO 9001, ISO 13485, ISO 27001 standards, and Quality Management Systems. Proficient in crafting detailed Test Strategies, Test Protocols, and Traceability Matrices, and skilled in executing and overseeing comprehensive testing, including formal V&V processes-SUMMARY OF SKILS:• Twenty plus years of experience in software manufacturing environment in various capabilities (As QA Manager, QA Lead, Automation Engineer and QA Analyst).• Extensive knowledge of all stages of SDLC and STLC, and both Agile and Waterfall methodologies.• Experienced in Medical Device and Life Science projects under federal regulations.• Experienced in leading multi-million dollar projects – including estimation, test planning, test documentation, resource planning and execution.• Excellent analytical skills and experienced with test planning, test protocols, traceability matrix, test execution, defect management.• Experienced in managing onshore & off-shore team members.• Experienced in designing and maintaining test lab with various virtual environments.• Experienced in writing, managing and implementing QA Policy and process documentations.• Proficient in mobile, web-based, cross browser/os compatibility, black box, functional, system, integration regression, database, GUI, end-to-end and acceptance test.• Quick learner. Ability to pick up and deliver quickly and efficiently.• Excellent ability to ‘attention to details’

Experience

1. Software Quality Assurance Lead, Medical Device

   Syncro Medical

   Apr 2018 — Present · Langhorne, PA, US

   Involved in the process of implementing Quality Management System in compliance with ISO 9001, 13485, and 27001 standards, ensuring the company\'s processes met international quality standards.Participate in periodic internal and external ISO audits, ensuring compliance with ISO standards and identifying areas for improvement.As a certified ISO 9001 auditor, conduct training sessions for new hires, including project managers, and perform periodic audits to confirm project compliance with the QMS.Conduct interviews for new hires, mentor team members to ensure that delivered solutions comply with testing standards, and uphold the QMS the project follows.Develop project-specific documentation, including Test Strategies, Test Protocols, and Traceability Matrices, supporting clients with submissions, including Software Requirements and Risk Analysis.Direct teams in conducting tests using various tools and simulators, ensuring compliance with testing protocols and producing formal records. Conduct software tool validations and document formal approval records.Conduct comprehensive reviews of project documents, including Project Plans, Design History Files, and Release Records, ensuring compliance with the QMS.Guide QA team members in designing test protocols and executing tests, including dry-runs, formal V&V, and producing formal records.Participate in internal and external scrums and retrospectives, contributing to continuous improvement and team development.Periodically conduct research on new tools and lead training sessions for the team, ensuring up-to-date knowledge and skills.

Education

• Skiltek College of Engineering, Kerala, India

  Post Graduate Diploma in Computer Applications, Computer Software

• SSI, Chennai, India

  Advanced diploma in RDBMS & Client/Server Programming., RDBMS & Client Server programming

• Mahatma Gandhi University, Kerala, India

  Bachelor of Science

• DPT Business School

  Client Server Programming

Skills

• Defect Tracking
• Jira
• Mobile Applications
• T-Sql
• Viva
• Software Documentation
• Sdlc
• Test Cases
• Scrum
• Asp
• Html
• Visual Basic
• Test Planning
• Integration
• Ios
• Web Applications
• .net Framework
• Veeva Irep Applications
• .net
• Pl/Sql
• Dreamweaver
• Regression Testing
• Xml
• Databases
• Java
• Sql
• Asp.net
• Agile Methodologies
• Adobe Platform
• Quality Assurance
• Rdbms
• Photoshop
• Software Project Management
• Hardware
• Oracle
• Microsoft Sql Server
• Software Quality Assurance
• Sitecore
• Testing
• Project Management