Elizabeth Minu Joseph
Austin
Summary
Quality engineer with a solid background in ensuring QMS compliance and coordinating CAPA projects. Skilled in developing comprehensive test plans and executing validation procedures, driving quality improvements in medical device development. Proven ability to analyze requirements and implement solutions in cross-functional teams.
Overview
14
14
years of professional experience
Work History
Quality Engineer IV
Flex
Austin
04.2022 - Current
- Updated procedures to ensure QMS compliance with internal and external regulatory requirements.
- Coordinated CAPA (Corrective and Preventive Action) projects by identifying continuous improvement opportunities.
- Worked on improving Quality Systems procedures to ensure compliance and alignment of work instructions for global integration projects.
- Ensure proper investigation for Root Cause Analysis using effective Root Cause Analysis tools and appropriate implementation action plans.
- Utilized quality management techniques to perform investigations and facilitate solutions.
- Wrote detailed QA Test Plan and Strategy documents meeting the industry standards.
- Performed test case creation and execution, analyzing results, and defect reporting and generating reports.
- Creation and review of Test Plans, Test Cases and Test Summary Reports.
- Analyze Quality System data and present established metrics to senior management.
- Tracked industry standards and legal requirements using compliance tracker tool, communicating with cross-functional teams to assess risks and impacts for regulatory updates.
- Coordinated logistics and document flow for internal audits and BSI inspections to support audit readiness.
- Supported by implementing actions for audit findings.
- Performed project Gap Assessments for FDA readiness.
- Developed familiarity with ISO 13485 and ISO 14971 standards to support compliance initiatives.
Senior V&V Engineer [Consultant]
RevereIT LLC
10.2018 - 03.2022
- Lead Project teams as Design V&V Engineer towards successful completion for NPI projects.
- Performed System, Integration, Functional, Data Validation and Regression testing of new/revised applications.
- Participated in Requirements reviews of the entire project and performed Regression Analysis based on design and development needs of the device upgrade.
- Developed comprehensive test plans, procedures, and implemented test scripts to ensure thorough validation of product features.
- Perform mechanical, RF, electronic, system and software testing: set up and execute test protocols, data collection, design of data templates, post-test processing, data presentation.
- Developed validation plans and procedures for V&V (MVVP) for the project.
- Analyzed requirements, developed, and executed test cases for facilitation of Interface Testing, Integration Testing, User Validation Testing, Charge System Testing and performed project related activities.
- Creation and review of Test Plans, Test Cases and Test Summary Reports.
- Identify and effectively communicate and resolve project issues and risks.
- Perform design verification and validation tests, including the development and execution of testing protocols and test report generation.
- Coordinate the implementation of scheduling of validation testing with appropriate department and personnel.
- Create Electrical/Radio Frequency and System Test plan and execute with specified focus on areas involving Electrical Engineering and RF test schedule generation and tracking.
- Develop protocols along with test reports for verification of design testing working with project teams.
- Ensure all design activities for project are performed conforming to external and internal requirements.
- Executed design and testing processes for components and mechanisms, ensuring product compliance with specifications and quality standards.
- Plan or implement research methodology or procedures to apply test principles of electrical and RF theory to engineering projects.
- Authored detailed test protocols, procedures, specifications, and reports to support development activities and facilitate regulatory compliance.
- Executed product design verifications to qualify vendors or design changes for product improvement.
- Authored design verification plan for the product family per Internal Quality Guidelines.
- Execute test protocols, qualification testing, SOPs, & status reports for improvement on existing/new products, equipment, & processes.
- Create/update test protocols for hardware, firmware, or software using Blackbox, Whitebox, Stress, and Acceptance using quality guidelines and requirement compliance.
- Work with Quality Control team to assist in the Quality Assurance process.
- Wrote detailed QA Test Plan and Strategy documents meeting the industry standards.
- Test case creation and execution, analyzing results, and defect reporting and generating reports.
- Apply knowledge of ISO 13485 and ISO 14971 standards to support regulatory compliance and quality assurance initiatives.
Software Engineer
GreenPath Inc
Farmington Hills
05.2018 - 08.2018
- The Software Engineer participates in the design, implementation, and testing of multi-tier applications.
- Implemented new features and functionality following established patterns and architecture.
- Developed Business Logic layer by implementing Object Oriented Programming Language(OOPs) features like Inheritance, Polymorphism, Abstraction and Encapsulation in C#.
- Conceptualized, designed, developed and deployed mobile applications for customers.
- Analyzed client business requirements and processes through document analysis, interviews, workshops, and workflow analysis to inform system design.
- Provide input into developing and modifying systems to meet client needs and develop business specifications to support these modifications.
- Participated in daily meetings for enhancing the features for the portal.
- Collaborated with Innovation teams to contribute as a User Experience designer.
- Organized User Experience meetings to enhance awareness of existing designs and promote a customer-centric approach.
Sr. Software Engineer
Realsoft Technologies LLC
Herndon
10.2015 - 05.2018
- Applied Agile scrum methodology to develop efficient 3-tier architecture applications.
- Developed Single page application and structured the JavaScript code using React.JS.
- Conceptualized, designed, developed and deployed mobile applications for customers.
- Developed Business Logic layer by implementing Object-Oriented Programming Language (OOP) features like Inheritance, Polymorphism, Abstraction and Encapsulation in C#.
- Analyzed business processes to identify challenges and developed database and communication software solutions.
- Managed database design, development and implemented data backup.
- Participated in Code review and Quality Assurance.
Program Coordinator (Intern)
The Ingenuity Center
Tyler
05.2015 - 08.2015
- Coordinated with Director for Educational Programs by scheduling meetings, preparing agendas and minutes, developing conference reports, implementing policies, and managing computerized data system.
- Facilitated monthly meetings with clients to document requirements and explore potential solutions.
- Translated stakeholder requirements into over 10 different tangible deliverables such as functional specifications, use cases, user stories, workflow/process diagrams, data flow/data model diagrams.
- Drafted and maintained business requirements and aligned them with functional and technical requirements.
- Implemented user-friendly UI design with HTML and CSS.
- Designed front end applications, user interactive web pages using content management system platforms such as WordPress.
- Ensured content accuracy on conference website and facilitated logistics for successful event execution.
Graduate Assistant
The University of Texas at Tyler
Tyler
10.2013 - 05.2015
- Assisted Project Directors in achieving goals for STEM conferences targeting K-12 educators across Texas.
- Evaluate risks related to requirements implementation, testing processes, project communications, and training saving the company on average $5,000+.
- Drafted and aligned business requirements with functional and technical specifications to ensure project clarity.
- Provided key performance metrics to the Head of IT on the deliveries and benefits realization of change implementations.
- Prioritized work within an agile team and maintained a backlog of future work for consideration/prioritization.
- Designed, documented and launched on-line conference registration process using ADOBE Forms, created reports for metrics and management of conference participant records, maintained related website for content and validity, and supported conference logistics for a successful outcome.
- Created a database for Ingenuity Center equipment, supplies, and resources for grant-funded educational programs.
Senior Analyst: PROCUREMENT SHARED SERVICES [SUPPLY CHAIN]
Flextronics International
Chennai
06.2012 - 08.2013
- Executed RFQ processes, conducted supplier bidding, analyzed MRP data, coordinated production orders, and established vendor relationships to enhance procurement efficiency.
- Consistently employed negotiation skills to secure the most cost-effective purchasing solutions for the company.
- Developed a robust network of suppliers, ensuring 100% compliance with company quality assurance standards.
- Acquired raw materials and production components to support manufacturing operations.
- Managed updates to the material master for inventory control, covering storage locations, MRP data like re-order, maximum, and minimum levels, lead time, and the maintenance of the Bill of Materials (BOM).
- Analyzed data to make purchasing decisions - Raw Materials using SAP.
- Facilitated communication among accounts payable, engineering, and inventory teams to effectively address and resolve discrepancies.
- Compiled metrics and production reports for timely delivery to suppliers, supporting operational objectives.
Education
Master’s - Project Management
Lindenwood University
MO, USA01-2020
Master’s - Electrical Engineering
University of Texas at Tyler
TX, USA01-2015
Bachelors - Electronics and Communication Engineering
Anna University
Chennai, India01-2012
Skills
- Jira and Minitab
- C and C programming
- Agile methodologies
- Scrum framework
- ISO 13485 and ISO 14971 compliance
- 21 CFR Part 11 standards
- Root cause analysis
- Corrective and preventive actions (CAPA)
- Design failure mode and effects analysis (DFMEA)
- Risk assessment strategies
- Project leadership
- New product introduction (NPI) projects
- Verification and validation engineering
Timeline
Quality Engineer IV
Flex
04.2022 - Current
Senior V&V Engineer [Consultant]
RevereIT LLC
10.2018 - 03.2022
Software Engineer
GreenPath Inc
05.2018 - 08.2018
Sr. Software Engineer
Realsoft Technologies LLC
10.2015 - 05.2018
Program Coordinator (Intern)
The Ingenuity Center
05.2015 - 08.2015
Graduate Assistant
The University of Texas at Tyler
10.2013 - 05.2015
Senior Analyst: PROCUREMENT SHARED SERVICES [SUPPLY CHAIN]
Flextronics International
06.2012 - 08.2013
Master’s - Project Management
Lindenwood University
Master’s - Electrical Engineering
University of Texas at Tyler
Bachelors - Electronics and Communication Engineering
Anna University