NATASHA LOHRAY Phone: 972-***-****

Plano, Texas, USA Email: adu7wd@r.postjobfree.com

US Citizen

EXPERIENCE SUMMARY:

• Overall 12 years of experience, out of which 9.5 years experience as Quality Assurance Specialist with a strong knowledge of Quality System Requirements including Medical device Design Control standards and regulations including ISO 13485, ISO 14971, IEC 62304, IEC 60601-1 and Medical Device Regulation ( EU MDR) .

• Developed Quality System processes and Risk Management deliverables for medical device software products and demonstrated an in-depth understanding of integration of risk management to design controls, CAPA, Complaints etc.

• Conducted Hazard analyses using available historical, test and market data.

• Managed CAPA processes as a CAPA owner and assisted CAPA team with investigation, 6M and 5 WHY root cause analysis, implementation and resolution planning of corrective and preventive actions to ensure products and processes are continually improved.

• Responsible for Post Market Surveillance complaint tend analysis process and reporting in accordance with global regulations.

• Actively participated in design change process to ensure the proposed changes to products are systematically and thoroughly analyzed and assessed.

• Managed the overall project lifecycle, which included proposal creation, scope definition/ negotiation, product cost estimation, resource planning, schedule planning, coordinating the activities of functional areas, budgeting, risk assessment and mitigation planning, task planning, project status reporting, and facilitating gate presentations.Facilitated scrum ceremonies like sprint planning, daily stand-up meetings, reviews, retrospectives, release planning, demos, and other Scrum-related meetings with the onshore and geographically distributed teams.

• “Servant Leadership” skills with a strong focus on customer requirements as well as needs of cross functional teams with the objective of achieving results in line with organizations values, principles, business and quality system requirements.

• Drove “collaborative, cross-functional teamwork” through the entire software project lifecycle by exhibiting strong collaborative and communication skills coupled with technical acumen, which helped drive and standardize and institute “quality centric” best practices within the organization. Natasha Lohray

ACCOMPLISHMENTS:

• Accoladed by management for conducting training sessions on “CAPA processes” i.e Initiation, Investigation, Implementation, Resolution Planning, and Verification of Effectiveness(VOE).

• Conducted trainings on the organization’s SOPs.

• Commended by executive leadership for significant contribution to the continuous improvement of vital business logistics in the organization through the “Kaizen process.”

• Initiated a culture of team building within the organization by managing quarterly team events.

• Editor of the software department quarterly Newsletter, which highlights employee achievements, milestones, and connects members of the organization through a common platform.

ACADEMIC QUALIFICATION:

• Certified CAPA Owner, Investigator, and Resolution Planner -Abbott Neuromodulation, Plano.

• Certified Scrum Master- Scrum Alliance.

• Bachelor’s degree in Computer Science- NIIT, Pune, India.

• Bachelor’s degree in Chemistry-Fergusson College, Pune, India. TECHNICAL SKILLS:

QUALITY SYSTEM

TOOLS

Enterprise Process Improvements through Quality for Post Market Surveillance(EPIQ), CatsWeb database for CAPA, Windchill for document reviews and release, Pareto tool for complaint trend reporting. PROJECT MANAGEMENT

TOOLS

Ms. Project, JIRA, Confluence, box, Visio, Ms. Office-Excel- Pivots PROJECT

TECHNOLOGIES

BLE communication, IBM Cloud, IBM Watson, C/C++, Java, Junit, Apple, Android, iOS

METHODOLOGIES Agile Scrum, Agile Kanban, Waterfall, Scaled Agile framework TESTING TOOLS HPQualityCentre,11.0, Toad, LDAP browser, QTP, Load Runner 6.5. Win runner 6.5, Telegence CSM

LANGUAGES C, C++, SQL, PL/SQL, Visual Basic 6.0, Visual C++, Unix Shell Scripting Natasha Lohray

EMPLOYMENT SUMMARY:

Abbott Neuromodulation Plano, TX( 09/19- Till Date) Software Design Quality Assurance Specialist

Responsibilities:

• Ensure through oversight and reviews that medical device software products and all associated deliverables are in compliance with the FDA code of Federal Regulations, ISO 13485, IEC 62304, ISO 14971, IEC 60601-1, EUMDR regulations, BSI requirements,company policies, and standard operating procedures.

• Responsible for oversight of quality processes and risk management throughout the software lifecycle from concept to commercialization.

• Demonstrated strong knowledge of Quality Management Systems and experience linking Risk Management Activities to various elements of the Quality System ( Design controls, CAPA, Complaints etc.)

• Responsible for hyper monitoring of post market surveillance complaint data for launched products through ‘Pareto Analysis’ and reporting the complaint trends during the monthly trending meetings.

• Responsible for generating, maintaining and updating Risk Management Tools( hazard analysis, FMEAs) for new product development projects and sustaining projects.

• Participated in project design reviews in various phases - Design Input, Design Output, Design Verification and Validation, and Design Transfer and reviewed/audited all associated design control deliverables and provided guidance to teams wherever required.

• Supported all sustaining maintenance activities i.e. iOS updates, SDK updates, new COTS device qualification for all on-market fielded software products.

• Responsible for document change request reviews and ensured completion of reviews and feedback in a timely and objective manner.

• Worked with cross-functional teams on streamlining design control processes through CAPA, Kaizen etc.

• Coordinated workshop events by gathering feedback and presenting insights on project adherence best practices and lessons learnt.

• Responsible for developing, updating and maintaining Design History File and Design Input/Output DATA BASES

Oracle 7.x/8.x/10i/10g, SQL Server 7.0 and MS-Access OPERATING SYSTEMS Windows 95/98/2000/NT/XP/Vista/7, UNIX, LINUX, Mac OS X GUI Visual Basic 6.0, Excel, PowerPoint

WEB HTML, SOAP, XML, JMS

HARDWARE IBM ES9000, IBM S390, IBM PC/AT, Sun SPARC, HP-9000, Macintosh, Intel Pentiums (II, III, IV) and RAID Servers.

NETWORKING TCP/IP, FTP, TELNET, HTTP, HTTPS, SSH

VERSION CONTROL Tortoise SVN, Git Bitbucket

Natasha Lohray

documentation.

• Proactively performed investigations to identify and implement best- in- class quality engineering practices.

Flex Medical, Irving, TX (09/16- 09/19)

Software Project/ Program Manager

Responsibilities:

• Managed the overall project lifecycle, which included proposal creation, scope definition/ negotiation, product cost estimation, resource planning, schedule planning, coordinating the activities of functional areas, budgeting, risk assessment and mitigation planning, task planning, project status reporting, and gate presentations.

• Facilitated scrum ceremonies like sprint planning, daily stand-up meetings, reviews, retrospectives, release planning, demos, and other Scrum-related meetings with the onshore and geographically distributed teams.

• Facilitated the team with making appropriate commitments through story selection, sizing, and task definition and participated proactively in developing and maintaining team standards, tools, and best practices thereby reducing product time to market significantly.

• Developed and implemented strategies for the program team, including developing a robust risk mitigation plan through DFMEA.

• Coordinated and communicated key interdependencies between project functions like hardware, electrical, software etc.

• Participated in design reviews, readiness reviews and Gate advisor meetings.

• Responsible for configuration management activities and license renewal of tools, software, and requisition of project resources.

• Led a site wide “PDM tool” implementation initiative for product data management. AT&T, Richardson, TX (07/13 – 08/16)

Test Architect & Scrum Master

Responsibilities:

• Test Architect and Scrum Master for various ONSTAR Connected Car projects wherein Analyzed the Business Requirement Document, Functional Specification documents to prepare Test Cases in HPQC

• Performed all aspects of QA best practices, staff coordination and communications, conducted functional, system and integration testing.

• Executed different test scenarios to cover all features of Uverse, Wireline, DTV, Wireless.

• Involved in the review meetings to ensure the QA Project Plan schedules were adhered to and the critical path activities meet the deadlines.

• Worked with the cross-functional managers to identify cross-team dependencies and manage inter- team tasks and dependencies.

• Involved in testing Database by writing SQL queries. Natasha Lohray

• Used TLGCSM to perform change events and validated the updates in Database and various adapter logs. Validated the Atlas Listener Log Files using Unix Commands through tools like Putty and Splunk.

• Involved in the Requirements Meetings, Review Meetings continuously with developers, business Analysts and Project Managers.

• Organized and facilitated sprint planning, daily stand-up meetings, reviews, retrospectives, release planning, demos, and other Scrum-related meetings.

• Reported projects and maintained effective channels of communication between internal team members and stakeholders and external customers.

• Worked for Production support for every release during deployment and Red hat period. Wise Info Pvt. (02/11 – 11/12)

Client: AMG

QA Test Engineer

Responsibilities:

• Reviewed test plans, test cases based on the BRD while interacting with clients in RAD and JAD sessions.

• Verified SRS, requirements and functional specifications. Tested the end-to-end functionality of applications. Involved in Black Box Testing of the application.

• Performed platform Browser oriented testing to render broad usage of applications.

• Consolidated all testing reports of the team execution percentages, test cases, status analysis, show stopper issues, and bug fixing ETAs, coordination with the development and release team, hosting meetings for testing requirements.

• Prepared test cases (Positive/Negative, Progression/Regression, Functional/GUI related) and created test descriptions for all the use cases for Functional/Load testing.

• Tested compatibility of software to run in supported Platform versions and Browsers.

• Used Win runner to successfully run the application for end-to-end testing, which is crucial in web-based application.

INTELLIGROUP ASIA PRIVATE LTD, INDIA (09/2009 – 01/2011) QA Test Engineer:

Responsibilities:

• Manually tested the functionality in QC environment.

• Analyzed and Executed Functional and Regression tests for Web service APIs.

• Wrote extensive test conditions for new BCR’s (Business change requests) based on the functionality.

• Coordinated with the Onsite manual QA team and the off-shore automation team to update, maintain and test the regression test cases according to the changes seen in each release. Natasha Lohray

• Identified, analyzed the impact and documented all defects with severity by comparing actual test results with expected results.

• Generated test reports and bug reports using Bugzilla. Natasha Lohray

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