Thuy Hoang c-Phone: 951-***-**** Email: aduj4z@r.postjobfree.com

Professional Summary:

Technical writing/editing/developing of complaint reports and electronic document management systems.

Solid project supporting/planning/coordinating, approval tracking, issuance of SOPs, batch record documentation, and CMS (Content Mgmt System).

Able to consult, build, and maintain solid working relationships in and outside of immediate department.

Extensive background in R&D and manufacturing, products support, procedures, process validation, QA/SQA, medical devices and other industries. Experience in development of new/existing medical devices.

Understand of a variety of FDA regulatory standards (Label/Document Review, DHF, CAPA, System Validation, 21 CFR 820, 510K submission, ISO 9000's/13485 regulations, specially EU MDR, FDA, GSDM, SDLC, SQA, SOX, PUC) relative to document design control management and company guidelines (GSOP/ECO, DOC, GMP) relevant in development of technical documents.

Understand of Project Management principles, concepts, practices and standards.

Knowledge of Product Lifecycle Management (PLM), Document Management Systems (DMS).

Understand of policies, procedures and guidelines relevant in development of technical documentation.

Technical writing as a career. Bilingual in Vietnamese and English.

Awards:

2018 Heart of Edwards Award

2017 Heart of Edwards Award

2015 Heart of Edwards Award

2014 Heart of Edwards Award

Helped Internal Audit & Help Releasing All Pending Products Documentation

Helped Releasing Centera ECR Processing

Helped Releasing S3 Atlas, Ultra, S-Future documents

Developed SOPs/IQOQs, Esheath J-Docs (Job Aids) Conversion, Process Validation GSOPs

2007 Abbott Vascular

Star Employee Nominee

Certifications:

05/2018

03/2018

02/2018

07/2016

06/2016

02/2015

03/2014

Completed of Training for Live Case

Certification of Training for Yellow Belt and J-Doc (Job Aids)

Certification of Training of 5S Lean Audit & Production Line Audit

Certification of Training for Inventory Disposition/NCR Containment (CAPA THV)

Certification of Training for Mistake Proofing/Reading and Interpreting Drawings

Certification of Training for Process Validation (PVP, IQ/OQ/PQ/EQ, TMV)

Certification of Training for Good Technical Writing

Edwards of Lifesciences

2012

Certification of Training for Project Management

Certification of Training for Design Control (ISO 13485/14971) & Risk Analysis (FDA QSR)

Certification of Training for FDA 510K Submission – Contents, Process, Pitfall

Certification of Training for BSI ISO 13485 Recertification Audit Preparation

Glidewell Laboratories

2006 – 2007

Certification of Training for Abbott Quality System Standards

Abbott Vascular

Technical Skills:

Windows 11/XP, MS Office Suite 365, Visio Professional 2019, Adobe Acrobat DC, Solidworks / AutoCad 2020, Ignite, TeamCenter 9, Agile, Oracle Fusion/CMS/DITA Document Process, Sourcetree, OneNote 2016, Snag-it 9.1, Snipping Tool, VSS (MS Visual SourceSafe), Documentum, Skype NetMeeting, WebEx, MS Teams, Slack, Confluence, BDocs, HTML Editor, Atom (Text Editor), Github (Code Editor), UCOS, DHTML, XML, RWD uPerform, Remedy 7.5, Lotus Notes 8.5, Minitab, Zebra Designer (Medical Device Label Design), Frame Maker 6.0 (Final Source Files), RoboHelp (Help System Files), Paint Shop Pro 4, PhotoShop, MS SharePoint, Master Control, Chrome, Internet Explorer/MS Edge, Firefox, Requirements, Jira (generate tickets), Rational – IBM tool (generate/store requirements), familiar w/ Cloud

Produce Diverse Documentation:

Routers/Forms, Change Order (Cos)/Request, Manufacturer Parts, SW Pkgs, SOPs/Job Aids, GMPs, Work Instructions/Tutorials, Maintenance Procedures/Checklist, Quick Start/End User/Installation & Configuration/References Guides, Engineering Specifications, Project Team Documentation Plan, Documentation Release Specification, SW Verification Plan and Protocol, SW Verification & Validation RPTs, Project Status Monitoring and Reporting

Professional Experience:

Dexcom, San Diego, CA Sr Staff SW Technical Writer/Project Coordinator (Contractor) 01/2021 – 09/2022

Write/Update technical documents that will support Dexcom’s mobile apps (provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes).

Write non-technical overview descriptions of components and services that provide other development teams with a summary of what the products do, and how to use them.

Create/Update CO (Change Orders), Requirements, SAD (SW Architecture Design), SRS (Syst Requirement Spec), SDS (SW Design Spec), RPT (Sw Unit Test), Code Reviews, and Documentation items. Generate all technical documentation and design specifications.

Implement Documentation System that included Engineering COs and templates for test protocols/reports.

Interface and receive feedback about the documentation from external teams and improve upon it.

Support submission of documentation required for compliance with our Quality System.

Monitor the project from initiation through delivery and support Program Managers in the execution of a project workstream from kickoff to completion.

Support in action item capture and information sharing to key stakeholders.

Help to track project metrics and data. Manage the scheduling of Zoom meetings with stakeholders.

Manage/Oversee of ongoing projects and serves as liaison between project management, planning, and project team execution. Review status of projects, manage schedules and prepare status reports

Perform duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

Perform various coordinating tasks, like schedule and along with administrative duties, also maintaining project documentation. Note taking during technical meetings.

Boeing, Long Beach, CA Sr Configuration Mgmt Specialist/Project Coordinator (Contractor) 04/2020 – 12/2020

Define, document and interpret product requirements relevant to certification, configuration, data and data management and engineering processes.

Develop, document and implement plans and processes to ensure products meet technical, data, regulatory and company requirements and to maintain configuration control.

Assist w/ development certification plans, integrated process architecture infrastructures, process models, product structure definitions and/or data requirements/data management processes. Works under general direction.

Execute implementation of project activities such as Product Lifecycle Management System Updates (MAP Agile), SAP data reviews, and documentation reviews.

Knowledge of “Systems Thinking” and engineering DWGs, DWG structure, part number configuration and control. Apply a “Systems Thinking” approach as it applies.

Assist engineers to update/improve on the aircrafts, and the team processes all the releases of the engineering DWGs. The DWGs might be 30+ pages, work w/ tedious.

Quality check on the design engineering DWGs and release DWGs and qualifications from one system and comparing it to the other system.

Manage project-related paperwork by ensuring all necessary materials are current, properly filed/stored.

Plan, identify and coordinate resources required over the life of the project or program.

Support the Production Engineering Managers and Management System to ensure key functional and business deadlines are met.

Monitor the effectiveness and performance of the project and project team and facilitates the development of contingency plans and recommended corrective actions as required.

Work closely with Program Managers to prepare comprehensive action plans, including resources, timeframes and research for projects.

BBraun Medical, Irvine, CA Sr Mfg Technical Writer/Project Coordinator (Contractor) 07/2019 – 04/2020

Write detailed descriptions of processing operations and properties of materials, and Test Specifications. Test and recommend changes in specifications.

Observe/Make notes and sketches processing operations and workflow diagrams. Import pictures into documents.

Develop standard work instructions for preventative and demand maintenance assignments.

Create/Develop Maintenance Checklists, operational procedures and technical reference materials.

Translate technical information for non-technical users; support other documentation to support business needs.

Work with colleagues across teams including product managers and engineers to gather information to create technical documents (SOPs, Job Aids, Work Instructions).

Communicate/Review technical documents with various departments to update edits/input from engineers.

Ensure accuracy of documentation and obtain approval through work-flow processes.

Serve as a final checkpoint for all documentation prior to release/publication; Perform tasks as assigned.

Perform document control duties to complete and manage updates, revisions, and version control.

Wells Fargo Corporation, Orange, CA Sr Technical Writer/Editor (BPP) (Contractor) 08/2018 – 06/2019

Research, analyze and translate technical information for technical and non-technical users.

Participate in establishing documentation guidelines; create and present graphical technical presentations.

Create/Develop Self-Help/Training documents and Checklists, Operational procedures and technical reference materials, User Guides for HMI Editor.

Develop WF Online desktop and tablet job aids (Digital Services Interactives Demos).

Draft/Edit/Format moderately complex to complex technical manuals/documentation, and web content.

Edit/Reformat technical documentation authored by others and ensure documentation is in compliance w/ corporate standards, internal style guides/templates and external regulations.

Convert documentation from one repository to another repository. Compile information in MS Word and transfer documents into PDF.

Reformat/Migrate online procedures from various repositories/CMS (Content Management System) into one CMS.

Coordinate documentation reviews w/ SMEs, Marketing, Product Managers, and Quality Assurance.

Ensure documentation meets editorial/usability guidelines, quality standards, technically accurate and consistent w/ regard to clarity, flow, organization, completeness, level of detail, formatting and readability across the whole global documents and across VL library.

Route/Publish documents in document control system, including associated quality system documentation.

Conduct audience analysis for moderately complex to complex problems and projects.

Work w/ project managers/teams and recommend appropriate implementation strategy, methods and plans for initiatives that typically impact multiple and/or complex systems, workflow or products w/ moderate risk.

Manage multiple projects and develop solutions for delivery to the fields; identify best practice and recommend new workflow and/or procedures.

Edwards Lifesciences LLC, Irvine, CA Sr Technical Writer/Complaint Reports Specialist (FT) 02/2013 – 07/2018

Work in cross functional product development teams to gather pertinent info to prepare and develop needed technical documentation (Process/MI (Manufacturing Instructions), SOPs, Test Protocols/Reports/Methods, PMP (Project Management Plans), Installation, MSDS, Material/Product Specs, Engineer DWGs, Technical Files, product development plans/processes.

Develop/Write Engineering Evaluation Reports (complaint reports) for returned THV (Transcatheter Heart Valves) Device Products.

Summarize findings, including a review of investigation QMS (Quality Mgmt Syst) Case Notes, CER (Customer Experience Reports), product analysis, imaging review, IFU (Instructions for Use), DFMEAs/AFMEAs, relevant labeling, prepping/training materials, Mfg Mitigations, Complaint Eval Matrix, Preliminary Engineering Evals, DHRs, work orders relevant to complaint events and formulate conclusions.

Disassemble/Test THV returned products in Pre-Deco and Deco labs to document root causes and to take pictures for developing complaint reports.

Perform technical/root cause investigations and document results per established procedures/timelines.

Evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, Quality Engineering review is documented prior to complaint closure.

Develop/Streamline complaint technical writing processes to aid in cycle time reduction.

Develop/Prepare/Analyze reports for coded complaints on a weekly basis as required.

Manage process for creation, approval, implementation/development of new/existing technical documentation.

Support Engineers to set up new equipment and tools for new production line (pilot line) of NPD projects.

Interview/Interacted w/ SME, R&D, Mfg., and stakeholders to document feasibility builds; to get source data to develop SOPs and process maps and to understanding of product, component/PN, and device changes.

Review raw materials from vendors’ manuals (ETOP (Engineering Turn-Over Pkgs), ES (Equipment Spec), FNS (Functional Spec), SDS (Syst Design Spec)), System/Equipment DWGs) to extract specific and pertinent info to create needed technical documents to support new production line/manufacturing development and QC/QA/QE.

Develop/Reviewed/Revised PVPs, SOPs, J-Docs (Job Aids), Work Instructions, Work Orders, IQ Protocols/Validation Reports, Test Methods, and Specs, complex GMP (Good Manufacturing Practices) Manufacturing procedures.

Organize meetings, documented initiations, verified labels and obtained cross-functional approval to ensure compliance w/ SOPs and checklists.

Edit/Revise technical documents for content, accuracy, graphics, format, style, and inconsistencies of process/development.

Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/within a clinical dossier.

Review batch-related documentation, ensure resolution of issues to ensure timely release of final product.

Test documentation against w/ products to ensure content, process steps, & standard graphics were accurate.

Work w/ operators to observe processes to documents procedures and performed walk-through to ensure documents are in compliance with regulatory and GMP guidelines.

Create ECRs and executed Change Orders to release all deliverables on Ignite System.

Assist in making changes to technical documentation within Ignite PLM system in support of NPD projects.

Manage the change control process from initiating the change to getting final approvals.

Identify issues raised by team members and updated feedback from reviewers.

Induct/Tracked lab/manufacturing equipment and tools onto Blue Mountain System for calibration.

Update DWGs and illustrations for use in documentation. Managed photographs for use in documentation.

Create job aids and lay out every step w/ pictures in the document for technician to perform the tasks.

Organize and efficient in deadline-driven and rapidly changing content/design for high quality documentation.

Glidewell Laboratories, Newport Beach, CA Sr Technical Writer/Regulatory Coordinator (FT) 01/2012 – 01/2013

Interface/Coordinate w/ project teams (R&D, Product Development, Mfg, QA/QC, RA, and Supply Chain) departments to prepare technical documents (Process/MI (Manufacturing Instructions)/FMEAS, Risk Management Plans/Analysis, Work/, SOPs, Test Protocols/Reports/Methods, PMP (Project Management Plans), User Manuals, Installation, Design Reviews, MSDS, Material/Product Specs, Engineer DWGs, Technical Files, product development plans/processes, and other technical documentation) based on products’ requirements and input from product development engineers.

Work w/ all project teams to develop/complete DHFs (Design Inputs/Outputs/Verifications/Validations, Transfer Design Plans/Files, Traceability Matrix) and prepare Regulatory Affair documentation mgmt for 510K submission.

Assist in preparation and edited of regulatory documents for final submission to regulatory agencies.

Review/Edit regulatory submissions for INP (Investigation New Products) and followed up internal/external audits as they pertain to RA.

Maintain DTF (Device Tracking Form) System and maintained Regulatory database and the filing system (both paper & electronic files).

Experience in achieving ISO 13485 by reviewing/revising SOPs, procedures. Tailored to characteristics of products, customers’ needs, Quality and Company guidelines, and ISO13485 and FDA Regulatory requirements.

Assist in preparation of documentation to support re-registration of label changes.

Edit labeling content, IFU labeling, Pamphlets/Product Labels, product/process changes, and product documentation to assure regulatory requirements compliance, consistency and accuracy.

Gather/Organized info (DWGs, Risk Plans/Analysis, Test Protocols/Reports, Product Specs (Material Specs), Technical Files, Process Flows, etc.) for DHF binders.

Update Product Cut Sheets, BOMs, DMRs, and Production Routers from ECOs.

Keep up to date w/ new or revisions to regulations/standards and assessing impact w/ employer’s current practice, revised procedures as necessary to maintain compliance.

Ensure final deliverables met policy standards such as registers and trademarks, safety and compliance requirements. Ensure deliverables were ready for internal/external use.

Support teams to document test methods, technical reports, labeling, DHF, etc. for specific market products and ensure REGULATORY compliance.

Support PM (Project Managers) w/ action items and project planning documentation for successful launch of product to market.

Knowledge of GLP (Good Laboratory Practices) guidelines, ISO (International Standard for Organization) 10993-1, routers/process sheets, BOMs, technical summaries, product assembly procedures & quality system requirements.

BBraun Medical, Irvine, CA Sr Mfg System Technical Writer (Contractor) 10/2010 – 12/2011

Work w/ SMEs, WPO (Work Package Owners) and Product/Project Owners, EO (Eq. Owners), and Engineering and Quality Management departments to determine document requirements to develop SOPs, MP (Maintenance Procedures)/Checklists, Process Flows, User Guides, Design Specifications for product requirements, validation test suites/reports, and protocol for validations (IQ/OQ/PQ and SV) as needed.

Create and manage test plans, scenarios, and test cases for verifying HMI (Human Machine Interface) toolkits and runtime applications.

Work with QA and Development teams to test the HMI software and PLC equipment in manufacturing environment.

Analyze/Organize/Transform complex raw materials into easy-to-understand information.

Re-evaluate GUI/UI (Graphic User Interfaces) and identified gaps for areas of improvement, and consistency.

Define/Create process/work flows and technical contents adhering to BBraun standards.

Capture screen shots for inclusion in documents and validated technical contents from vendors/engineers.

Ensure project documents (user manuals, policies/procedures, training materials) met standard/correct formats/styles and adhered to BBraun development methodology standards as well as FDA regulatory requirements.

Track/Route documents for review and approval process according to document priorities.

Eliminate roadblocks. Managed versions/revisions and change control of documentation.

Responsible for all approved/new documents and uploaded/published onto ShareNet (BBdoc).

Coordinate/Prepared controlled document packages (SOP, cGMP documents, and 6S Sigma, etc.) from all departments for regulatory submission, training, internal/external audit as required.

Kaiser Permanente, Corona, CA Sr IT Technical Writer (Contractor) 01/2009 – 09/2010

Develop needed documents (procedures, user manuals, system operation, and recovery instructions, presentations, and system design documents) in an organized, consistent, professional manner, while remaining current in system development methodologies and compliant w/ system development regulations.

Document all processes/SOPs (including cataloging and indexing) for Kaiser’s DocuShare site.

Proofread controlled documents at all levels of complexity consistent w/ current formats and department style guides using EDMS (Electronic Document Management System).

Edit content for readability. Tested/validated content for usability.

Identify/Fix documentation errors including outdated content, broken links and missing content and fulfilled/analyzed documentation needs and usage in context of KP Information Security standards.

Support SOX Auditors to identify issues and applied problem-solving techniques to troubleshoot problems.

Track status of document changes and ensure changes had appropriate level of approval.

Abbott Vascular, Temecula, CA SAP Sr.Technical Writer/Project Coordinator (FT) 09/2006 – 12/2008

Work w/ PMs/Technical Lead and Application Developers to gather required info to develop/update Project Plans/Assessments, Specifications, Test Plans/Cases, Requirements/Requirements Matrix, Timelines, Hi-Level Designs, Implementation, User Manuals and other SW project documentations.

Assist PMs in developing, integrating, maintaining, and analyzing plans and schedules that support requirements and optimum execution of engineering projects. (Ensure that project and team schedules were vertically and horizontally integrated).

Deliver SDLC (SW Development Lifecycle) documentation required for Application Development projects and designed/managed lifecycle of documentation that Abbott internal consumers use worldwide.

Act as liaison between SQA and PMs for SQA processes/activities and prepared/maintained SVR (Software Validations Reports) Production Report and PER (Phase End Reviews) for monthly and quarterly.

Coordinate w/ document authors and approvers to ensure documentation was accurate in accordance w/ quality document controls. Coordinated of project meetings and participated in system design sessions.

Facilitate routing and approval of quality documentation utilizing electronic document management tools (SAP).

Education:

2021 – present

BS, Info. Quality System/Quality Assurance for Medical Devices (Pursuing)

University of CA, Irvine Extension, CA

2001 – 2003

MCSD (MS Certified Software Developer)

SMU - Dallas, TX

1994 – 1996

AS, Information System

Asher College of Business - Atlanta, GA

1991 – 1993

AS, Pharmacy Technology (Pharmaceutical Sciences)

Atlanta College of Pharmacy - Atlanta, GA

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