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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLE The Villages, FLSeeking a quality assurance tester role. I am an action-oriented and integrity-driven leader offering over 15 years of experience in the medical device, financial, information technology, and agricultural fields, with emphasis on methodology, analysis, end-user comprehension, and project management. History of delivering cost-saving solutions for projects on time. Passionate about improving processes and people.WORK HISTORYSenior Content Developer (remote) for Terumo BCT, Lakewood, CO, 9/23-presntAuthors, edits, and reviews technical and end user documentation for external customers, with a focus on the blood, cell, and plasma extraction medical device.Works with internal resources to produce a variety of end user support materials, such as requirements, IFUs, Operators Manuals, Verification and Validation documentation.Technical Writer (remote) for Remarque Systems, North Carolina, 6/22-9/23Authors, edits, and reviews technical and end user documentation for external and internal customers, with a focus on the clinical trial software.Works with internal resources to produce a variety of end user support materials, such as technical documentation, infographics, screenshot markups, and end user support videos.Senior Technical Writer for Sentera, Saint Paul, MN, 1/20-5/22Wrote documentation to support agricultural drone sensors and analytical software that uses artificial intelligence (AI) and face recognition to identify plants and weeds with specific GPS coordinates in order to prescribe exact herbicides and pesticides for cost and environmental savings measures.Created document management system.Created tech support website for customer support facing help articles and videos with voice overs.Created templates to support documentation.QA Testing/Test Case Writer Consultant Medtronic/Blue Sages, Fridley, MN 9/18-11/19Wrote test cases for Medtronic medical devices to represent software requirements.QA tested Medtronic devices.Senior Technical Writer/Business Analyst consultant for Verb Surgical (Google) & Johnson+Johnson, Minneapolis/Mountain View, CA, 4/19-11/19Created, revised, and edited surgical robot software designs and protocol documents for a start-up.Prepared documentation to meet FDA standards (21 CFR 820, ISO 13485:2016, ISO 9001:2015), while working closely with hardware engineering and Doc Control.Created Engineering Change Orders through Agile system.Traced requirements from risks to test results.Provided feedback to management regarding FDA standards as related to documentation.Created test run reports, installation guides, and release notes.Led team of technical writers when work instruction, Standard Operating Procedures SOPs, Development Plans DPs, and guidance were minimal. Assisted engineers with documentation.Business Systems Analyst/ Senior Technical Writer contractor for Wells Fargo, St. Louis Park, MN, 07/2018-04/2019Overhauled supporting documentation for Software Development Lifecycle Policy & Procedure within the Risk Department. Developed simplified single document to assist users in meeting SDLC requirements.Audited policy and procedures to meet corrective action. Used JIRA/Agile/Scrum methodology for any change requests. Maintained BRD, SRS, TRD, and template documentation. Collaborated with Governance, Support, Development, Communication, Publication, and Policy teams to meet documentation requirements using Documentum and SharePoint.Business Analyst/Design Labeling Engineer/ Senior Technical Writer contractor for Medtronic, Fridley, MN, 02/2016-07/2018Assisted Patient Care Devices Neuromodulation (spine/brain) and urinary stimulation departments with embedded firmware, software, system, mechanical, electrical, requirement, testing engineers in project documentation from start to finish, including requirements, SDD, verification, validation, Corrective and Preventive Action CAPA, Failure Mode Effects Analysis DFMEA.Prepared DHF/DMR documentation for FDA audit, including risk/hazard/requirements tracing, while working closely with Regulatory Affairs.Used CodeBeamer to move requirements from PTC Windchill Integrity.Attended development team meetings and gathered requirements.Provided key metrics reports. Provided mock-up solutions and user case needs to management.Used eNovia/Windchill to create Engineering Change Orders (ECO). Requests (ECR), and BOM.Created quality management templates for every phase of the project, tailored for the team, using ISO 14971, IEC 60601-1, ISO 9001 as guidelines.Used Documentum/MRCS to manage DHF project documents.Worked with the Mobile Device Management team to create app-based patient care.Created department wiki page and SharePoint site.Collaborated with engineers and Functional/Change Review Board to create documentation when making a change request to a product.Used Rational ClearQuest, RequisitePro, LabWare, and Spotfire to create or assist in documentation for engineering team.Edited, wrote, and executed test plans, edited tests written by others, documented found errors, and provided in-depth to rollout imbedded software for urinary incontinence device.Experience using oscilloscope, digital meter, and other equipment for testing.Senior Technical Writer/Business Analyst for Oracle, Minneapolis, MN, 01/2005-01/2016Wrote/edited hundreds of manuals each year (user, operations, installation, online help, defect docs, data model, integration, quick start guides, white papers, release notes), for major customer-facing retail projects. Responsible for multiple key initiatives using software development lifecycle.Led documentation team to convert multiple RoboHelp user guides to FrameMaker/XML.Improved department credibility with the subject matter experts.Developed document templates, style guide, and troubleshooting document for online help projects to adhere to corporate standards and visual identity.Wrote single-source, context-sensitive Oracle help for the Web at Oracle consistently on time and within budget. Wrote corporate-wide Web site download technical installation and conversion templates and manuals. Used SDLC, Waterfall, and RAD methodology.Business Analyst/Senior Technical Writer/Information Design/Project Manager for Spherion, St. Louis Park, MN, 10/2004-10/2005US Bank, eFunds, Wells Fargo, Xcel Energy, Best Buy, ELCA Board of PensionsPresented use cases as a speaker at the Information Technology Coding and Computer conference.Bachelor of Science-Technical Communication/Animal Science, University of Minnesota. |
