Tracy Dunlap Millar Email and Phone Number
Tracy Dunlap Millar's Location
Cortland, New York, United States, United States
Tracy Dunlap Millar's Contact Details
Tracy Dunlap Millar work email
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Tracy Dunlap Millar personal email
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About Tracy Dunlap Millar
Certified Software Quality Assurance Engineer experienced in new product development design controls for FDA medical and commercial aircraft control systems using Agile and Waterfall techniques. Knowledgeable in transaction print technology, USB, USPS distribution technology, signal processing, missile engageability and automated warehouse distribution systems. Take charge individual with a proven ability to quickly learn and lead projects to completion. Effectively works with a broad group of functions. Achieves corporate objectives while optimizing the approach to meet requirements. Previous government security clearances held. * Software Quality Assurance * Computer Application Design, Programming, Testing and Simulation* Mathematics * Technical Administration and DocumentationSeeking to bring value to the Central New York area as a Quality Assurance professional.
Tracy Dunlap Millar's Current Company Details
Tracy Dunlap Millar Work Experience Details
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Advanced Quality EngineerStryker Sep 2022 - PresentKalamazoo, Mi, Us
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Quality EngineerTransonic Systems Inc. Nov 2021 - May 2022Ithaca, New York, Us* Responsible for design and development of quality including adherence to procedures for designinput, review, output, verification and validation and transfer as well as initial production. * Solely responsible for bringing the Customer Complaints process back on schedule. This encompassed the resolution of over five hundred past complaints in addition to disseminating complaints that came in daily.* Monitored and ensured compliance with regulatory requirements (e.g., compliance with FDA, MDD/MDR, ISO 62304) and quality system requirements (Transonic Quality System). * Advised, assisted, and lead the project team if any proposed course of actions affect company or product compliance.* Reviewed and approved test and validation documentation.* Participated on Risk Management and Risk Analysis review for clinical and research products. Oversee and facilitate reportability decisions for incoming customer complaints.* Initiated and facilitated continuous improvement projects for Quality Systems as well as support continuous improvement efforts from other departments.* Worked closely with project staff to initiate Quality Plans, provided project documentation guidance, and coordinated and conducted project audits to ensure quality standards. -
Assistant Quality Manager - TechnologyWcg – Verasci, Inc Aug 2021 - Nov 2021* Worked closely with project staff to initiate Quality Plans, provided project documentation guidance, and coordinated and conducted project audits to ensure quality standards.* Ensured SOPs and other procedures were kept current and worked with other VeraSci staff to update procedures as necessary.* Assisted with the preparation and completion of Sponsor audits and regulatory inspections.Kept current with relevant regulations/guidelines.* Assisted with the completion of internal system audits and corresponding documentation to determine the level of compliance with applicable regulations.* Assisted with vendor audits and assessments as needed.
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Software Validation Engineer - Quality AssuranceIcm Controls Mar 2020 - Jun 2021North Syracuse, New York, Us* Worked on various UL 1998 projects. This includes the responsibility in overseeing electrical, mechanical, software and test engineers to develop accurate documentation in order to comply with the UL 1998 standard. * Responsible for numerous Corrective and Preventative Actions (CAPAs), Production Part Approval Processes (PPAPs), ISO 14001:2015 EPA Environmental resolutions and internal auditing which focus on design controls and production.* Solely responsible for the development of a hardware and software design control system to be used according to UL 1998 and ISO 9001:2015 development standards for HVAC control systems. This includes the creation of templates and instructional documentation. -
Lead Verification And Validation Engineer - ManagerRheonix, Inc 2018 - 2020Ithaca, Ny, Us -
Systems Test EngineerRheonix, Inc 2018 - 2018Ithaca, Ny, Us
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Software Test EngineerRheonix, Inc 2016 - 2018Ithaca, Ny, Us* For the Encompass MDx Workstation, reviewed and approved documentation for software and hardware requirements, architecture, design, risk analysis, unit, integration, system and SIUV testing, as well as tool validation testing (IQ/OQ/PQ). This was to assure that all documentation and testing complied with software and hardware requirements conjointly. * Main contributor in the development of hardware verification tests. Also developed software verification tests and tool validations (IQ/OQ/PQ). Responsible for authoring software and hardware regression analysis. Worked with lead hardware and software engineers to guarantee compatibility for the requirements developed for the Encompass MDx system.* Main contributor for the development of the EncompassMDx Hardware Architecture document.* Developed and maintained hardware and software tracing for the Requirements Traceability Matrix (RTM) and Software Verification Report (SVR).* Authored Rheonix’s Software Development Process Standard Operating Procedure (SOP).* Managed interns (co-ops) and full-time employees (approximately 10 employees) for software development, verification testing and tool validation testing.
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Senior Software Quality Assurance EngineerTransact Technologies 2015 - 2016Hamden, Connecticut, Us* Led the effort to develop a software quality control system which stresses the design control development process. This involved developing process standards, procedures and document templates.* Led the test verification and validation process for the Printrex 980 Driver, Atlas and ServerPort systems.* Developed, reviewed and approved design verification and validation strategies for the FST 9700 and AccuDate 9800 Food Service Terminal (FST) Turbo system.* Reviewed payloads (user testing) which were used for the FST 9700 and AccuDate 9800 FST Turbo systems. -
Senior Software Quality Assurance EngineerWelch Allyn 2011 - 2015Skaneateles Falls, New York, Us* Led design control guidance to development teams developing software medical products for new product development. Determined plans,design inputs, design outputs, software design control processes, verification that outputs matched inputs and validation so that the devices met their intended use. For all projects they were on time and at or below budget with estimated yearly revenue of $50M.* Developed, reviewed and approved design verification and validation strategies, component and specification qualification plans and clinical and field trial and extended customer use plans.* Negotiated in Configuration Change Board meetings which were the result of software design reviews, verification and validation testing or clinical and field trial results.* Skilled in safety, efficacy and hazard analysis, Failure Mode and Effects Analysis (FMEA), Software Failure Mode and Effects Analysis (SFMEA), Risk Assessment Summary (RAS) and Fault Tree Analysis (FTA). This includes Essential Design Outputs (EDOs).* Oversaw the development and review of process control documentation. This included plans, protocols and test executions.* Managed and maintained the Requirements Traceability Matrix (RTM).* Managed Design Transfer activities which included development of the Software Verification Report (SVR) and Final Design Transfer Design Review and Safety and Efficacy Review. * Maintained the Device History File (DHF) to meet FDA and ISO requirements, specifically FDA 21 CFR 820.30.* Spearheaded standard QA procedures for R&D Service activities which reduced review times by 50%. -
Software Quality Assurance EngineerMcci Corporation 2007 - 2011Ithaca, Ny, Us* Developed, documented and maintained test plans and procedures to test drivers and firmware products/test tools for USB manufacturers. Developed test reports, problem reports (JIRA) and test logs were maintained.* Managed product technical test material for meeting technical requirements, technical correctness and clarity from India. These included test plans, test procedures and test reports using resources from India and Ithaca.* Performed certification tests on products to ensure that they complied with industry specifications. -
Senior Software EngineerNortel Government Solutions 2003 - 2007Fairfax, Virginia, Us* Monitored and evaluated real-time software, testing and software documentation for the USPS Automated Package Processing System at Lockheed Martin’s Owego, NY facility. Determined the requirements within the Statement of Work were correctly implemented according to USPS’ SDLC Standards. * Monitored PVCS MTSC problem reports to ascertain STR/SCR correlation or new STR/SCR submittal. This assured build release inclusion.* Held signature authority for the approval/disapproval of Class I software changes.* This position required a USPS sensitive clearance level. In addition, held a DoD Secret level clearance. -
Senior Software Design EngineerBae Systems Controls, Inc. 1998 - 2002* Led real-time software code design and update, build development, unit testing (automated and manual), functional system teststand checkout, quality assurance, problem reporting, software configuration management and weekly project tracking for commercial engine control programs. These programs were in accordance to DO 178-B certification requirements. * Managed of up to 13 software engineers for the update and review of software code modules and unit and functional system tests. These programs were delivered on time and at or below cost.* Responsible for software development planning and technical process documentation in accordance with DO 178-B standards. Also responsible for project estimation and tracking and extensive proposal writing.
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Software EngineerOld Dominion Systems Incorporated Of Maryland 1997 - 1997
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Senior Systems Software EngineerPlanning Systems Inc. 1986 - 1997Us -
MathematicianVitro Corporation 1985 - 1986
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Advanced Systems AnalystHartman Material Handling Systems, Inc. 1982 - 1985
Tracy Dunlap Millar Skills
Quality Assurance
Software Development
Software Documentation
Testing
Software Quality Assurance
Fda
Integration
Software Engineering
Cross Functional Team Leadership
Medical Devices
Embedded Software
Validation
Software Design
Firmware
Agile Methodologies
Embedded Systems
U.s. Food And Drug Administration
Device Drivers
Verification And Validation
Mathematical Analysis
Medical Device R&d
Test Planning
Technical Leadership
Mathematical Programming
Computational Mathematics
Mathematical Modeling
New Product Qualification
New Product Release
New Product Validation
Technical Documentation
Technical Analysis
Agile And Waterfall Methodologies
Product Development
Design Control
Research And Development
Software Development Life Cycle
Tracy Dunlap Millar Education Details
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Cortland High School -
Rochester Institute Of TechnologyComputational Mathematics
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The Catholic University Of AmericaEngineering Management
Frequently Asked Questions about Tracy Dunlap Millar
What company does Tracy Dunlap Millar work for?
Tracy Dunlap Millar works for Stryker
What is Tracy Dunlap Millar's role at the current company?
Tracy Dunlap Millar's current role is Certified Software Quality Engineer specializing in FDA and FAA.
What is Tracy Dunlap Millar's email address?
Tracy Dunlap Millar's email address is tr****@****nic.com
What schools did Tracy Dunlap Millar attend?
Tracy Dunlap Millar attended Cortland High School, Rochester Institute Of Technology, The Catholic University Of America.
What skills is Tracy Dunlap Millar known for?
Tracy Dunlap Millar has skills like Quality Assurance, Software Development, Software Documentation, Testing, Software Quality Assurance, Fda, Integration, Software Engineering, Cross Functional Team Leadership, Medical Devices, Embedded Software, Validation.
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