Software Quality Engineer

MARLA GUENTHER-SMITH

***** **. ******* ***** *****, California 92064

619-***-**** adt8gp@r.postjobfree.com

SOFTWARE TEST / QUALITY / VALIDATION

AREAS OF EXPERTISE

Software Verification Software Validation Requirements Analysis Quality Assurance Requirements Verification Test Planning Test Case Development Manual Execution Traceability Regression Analysis and Testing Defect Tracking & Resolution Release Management Reporting Standard Operating Procedures Project Coordination Software Development Lifecycle Requirements management software FDA Compliance Microsoft Office Cross discipline collaboration ISO 13485 QMS compliance

21 CFR Part 820 SAP

PROFESSIONAL EXPERIENCE

ACCRIVA Diagnostics, San Diego, California 2014-Present (a.k.a. Werfen)

Global leader in blood diagnostics focused on providing timely, precise information leading to improved treatment outcomes with Anticoagulation management, Antiplatelet Medication Reactivity Testing, Co-oximetry Assessment, and Skin Incision Devices.

Sr. Quality Engineer, Software (2016-present)

Collaboration with all departments, that utilize non-product software for a regulated activity, to assure QMS and validation compliance. Support to departments such as Manufacturing, R&D, Incoming Inspection, QMS, Labeling, Reagents, SAP, FPT spreadsheets and more for complete and accurate validation documentation. Maintenance of master validation profile to assure validation state of non-product software is identifiable and up to date. Responsible for SOPs that govern the process for non-product software validations.

R&D, Staff Engineer, Software (2014-2016)

Coordinated and collected software requirements for new product development. Maintained revision control of all software requirements using Caliber, Requirements Management Tool. Developed software test protocols used for Dry Run testing during design phases, with formalizing all changes to then be made available for Design Verification. Executed testing for design builds, formalized builds, and formal design V&V. Organized and maintained R&D DHF for new product documentation control. Collaborated with product team for software traceability matrix data.

HOSPIRA, San Diego, California 2003-2014

Global leader in production of generic injectable pharmaceuticals, as well as integrated infusion therapy and medication management systems, with more than 15,000 employees worldwide. Formerly the hospital products division of Abbott Laboratories.

Requirements Analyst (2013-2014)

Key point of contact for functional requirements gathering and management in support of medical infusion pump software. Record and update issues into the defect tracking tool. Liaise with internal and external cross-functional teams to resolve issues with software requirements. Support various SDLC phases through traceability analyses of requirements at each stage. Maintain proper historical preservation of all requirements for FDA submission by authoring and editing comprehensive documentation. Drive ongoing compliance measures to ensure alignment with FDA regulations.

Selected Achievements:

Evolved to manage ever-changing requirements details through constant communication and coordination between diverse internal working groups.

Maintained weekly training alignment with strict standard operating procedures compliant with FDA and ISO 13485 regulations.

Expertly maneuvered through the complex requirements management tool, Telelogic DOORS, as well as JIRA and DevTrack for defect tracking.

Eliminated duplicate efforts by identifying separately reported issues of the same issue and consolidating their work efforts.

Advanced goals of customer satisfaction and alignment by analyzing software requirements to ensure achievement of stakeholder and user goals / needs.

Senior Software Verification Engineer (2003-2012)

Conducted requirements analysis for development and enhancement of mission-critical software, including an infusion pump application, a medication management application, and embedded clinical software for hardware devices. Leveraged requirements to create test cases and session-based tests. Handled verification review as part of the requirements definition phase. Managed traceability between requirements, test coverage, and test results. Contributed to weekly defect resolution meetings. Delivered all test regression analyses in partnership with software developers. Utilized and monitored issue reporting systems to flawlessly support workflows throughout issue reporting, resolution, and closure.

Selected Achievements:

Ensured thorough, comprehensive test coverage that facilitated collection of physical data and evidence of pass / fail results.

Seamlessly managed thousands of test cases using Telelogic DOORS test repository to create, administer, and track tests and requirements.

Prevented numerous defects through effective, quality-oriented verification review prior to formal verification.

Supported team members in achieving goals by fostering clearer understanding of the impact of all contributions.

Promoted adoption of best practices and improved testing methodologies by assisting with a trial of Agile methodology and Scrum practices.

Maintained alignment with strict standard operating procedures compliant with FDA and ISO 13485 regulations.

Aided in design and development of a proprietary internal tool for test result tracking, with enhanced features for mandatory history file preservation and project traceability.

HEWLETT-PACKARD, Rancho Bernardo, California 2002-2003

$112 billion multinational giant in information technology development and sales.

Software QA Lead – Sapphire

Spearheaded regression testing activities for the Home Photo Printing division of HP, focused on test planning and execution for photo printer drivers. Oversaw all integration testing and localization testing on multiple test PCs, up to 5 operating systems, and a setup consisting of combinations of up to 9 printers. Prepared reports of test results and submitted to management.

Selected Achievements:

Evolved to the challenging needs of localization testing in English and more than 20 foreign languages.

STELLCOM, San Diego, California 1997-2002

Premier systems integration firm, founded in 1984, offering technology solutions in-house as well as on-sight, with a team of 50-100 employees.

Software QA Engineer

Managed various client engagements to provide software QA administration and support for diverse in-house projects. Created and executed test suites across hardware, software, and firmware platforms. Defined testing protocols specific to each unique project.

Selected Achievements:

Successfully delivered test management projects for Lap Pad devices, Defibrillators, Nokia PowerClip accessories, diverse drivers, and wireless connectivity.

Adapted to constant changes in business cycles and solutions to create custom testing protocols.

Leveraged expertise in diverse defect tracking systems to ensure swift and timely resolution of all bugs.

Fostered ongoing communications and collaboration with engineering teams to facilitate the build process and maintain consistency in quality control.

ADDITIONAL ROLES

Software QA Analyst, Bridge Medical / Stellcom (1999-2000): Oversaw aspects of testing and testing documentation for medication error prevention software project, with testing spanning unit level, smoke, regression, full functionality, and performance testing. Defined the architecture for test documentation. Performed requirements analysis and review throughout the development lifecycle. Evaluated algorithms to plan timing scenarios for predicting proper due times for patient medications and appropriate preventative warnings. Handled database analysis. Implemented HL7 standards for patient medication order information management. Configured, maintained, backed up, and restored test databases.

Software Test Engineer, C2i Solutions / Stellcom (1998-1999): Took an instrumental role in the Y2K transition by conducting tests on internal NACM software – including handling Y2K assessment, test case planning and development, and test execution on internal capital management applications in a client / server environment. Prepared Y2K compliance reports for internal documentation. Key to completion of SIA industry-wide Y2K compliance testing.

Software QA Analyst, Qualcomm / Stellcom (1997-1998): Contributed to 2 MIS engineering projects for CM, MIS ASIC, and configuration management. Authored test documents. Conducted testing of customized PeopleSoft modules. Prepared and keystroked user documentation. Provided post-implementation user support. Handled independent QA testing, defect control, and process control for release of internal configuration management software. Built regression testing platforms. Edited test plan templates and methods.

Earlier positions include QA Manager for GLOBALINK, INC. and Software QA Analyst for JOSTENS LEARNING CORPORATION. Details available on request.

FORMAL EDUCATION

Bachelor of Science in Business Administration – Marketing

California State University – Northridge, California

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