SUMMARY:

• Accomplished Professional with 25 Years of experience in Component to System Level Electronic/Hardware Product Development as an Engineering Technician primarily in Medical Device, Pharmaceutical, and Security Motion/Subsonic Glass Break detectors; Senior Technical Writer/Editor/Proofreader
• Liaison between Engineering, Manufacturing, Document Control, Facilities Operations, and QC/QA. Development of Sub - assembly/System level Assembly and Testing (Test Plans Test Methods, Test Reports for Engineering and Production Personnel); Advanced Oral communication and Organizational skills; Project Manager;Member of the Society for Technical Communication Quality Management System Standards: Class 1, 2, and 3 Devices
• Experience with EN ISO 14971:2012 Risk Management (DFMEA, PFMEA)
• PLM Documentation Software applications; GMP, GDP
• Protocols, SOPs, and Work Instructions; Process Validation: EQ/IQ/OQ/PQ1/PQ2; CAPA;
• Data gathering and documentation creation. ISO 9000/13485/85364 ; FDA QSR 21 CFR Part 820 Compliance; 483 Warning Letters, Consent Decree; CAPA; UL & CE Marking Compliance
• Product Validation; FDA & Security Device Regulatory Compliance Documents; Book Manuscripts; Cookbooks; PhD Dissertations

ADVANCED COMPUTER SKILLS:

Microsoft Office: Word, Excel, PowerPoint, Publisher; Outlook, Paint, Visio

Adobe Applications: FrameMaker, PDF, Photoshop Insertion of photos/graphics using Acrobat, InDesign, Illustrator; SolidWorks, Visioneer PaperPort/Scansoft, SAP, eDOCS

Electronic Data Management (EDM ): TrackWise/Documentum/SharePoint/LiveLink

Project Lifecycle Management: Optimal Trace, Matrix One Application Developer, some Windchill

PROFESSIONAL EXPERIENCE:

Senior Technical Writer/Editor/Proofreader

Confidential, Jackson, MI

Responsibilities:

• Editing/Proofreading of Non-Fiction Book Manuscript Writing/Editing of Risk Analysis Documents and Manuals for New Medical Devices
• Writing and Editing of Risk Management files for various Medical Devices in R&D: Risk Assessment Risk Management Plan, Hazard Analysis, DFMEA, Risk Management Report, SOP’s, Work Instructions.
• Research, develop, and write technical documentation (SOPs, protocols, reports, manuals) for internal and external use to comply.
• Reviewed, improved, and maintained existing documentation.
• Utilized Design, Regulatory Compliance, Process Engineering, and Marketing SME's to obtain required Technical Data.
• Assist with CAPA investigations and reporting.
• Use of Word, Excel, PDF, Outlook, SAP, eDOCS

Senior Technical Writer

Confidential, Reading, PA

Responsibilities:

• Writing and Editing of Risk Management Documents for Remediation Project to comply with EN ISO 14971:2012 Standard: Risk Management Plans, Risk Management Reports, Hazard Analysis, and DFMEAs.
• Utilized Design, Regulatory Compliance, Process Engineering, and Marketing SME's to obtain required Technical Data.
• Use of Word, Excel, Agile, and Outlook.

Senior Technical Writer

Confidential, Fort Washington, PA

Responsibilities:

• Design, creation, revision, and maintenance of SOPs, Work Instructions, and On The Job Training/Performance Checklists for Calibration of Electronic Equipment in the GMP Analytical Laboratory for the production of OTC (Over the Counter) Drugs to assist with the remediation of documentation under the Confidential Consent Decree.
• Utilized SME's, design specifications, user and system manuals, etc. for guidance.
• Gathered information from subject matter experts and the users of the processes to explain in simple language scientific and technical ideas that are difficult for the average reader to understand.
• Developed Work Instructions that contained detailed instructions that specify exactly what steps to follow in order to complete an activity.
• Communicated activities and results to the site leadership.
• Use of Word, Excel, Visio, Outlook, Sharepoint, and Abobe (PDF).

Technical Writer/Editor/Proofreader

Confidential, Loveland, CO

Responsibilities:

• Technical Writing, Editing, and Proofreading of Book Manuscripts, Cookbooks, Manuals Term Papers, Dissertations.
• Editing of Process Validation Documents: EQ/IQ/OQ/PQ1/PQ2 Documents for a Medical Device
• FDA Quality Compliance Technical Writer.

Technical Writer/Editor

Confidential, Oceanside, CA

Responsibilities:

• Provided routine, non - routine, and complex information services for multiple
• SOPs and Work Instructions for Upstream and Downstream Drug Production operations.
• Functioned independently in supporting routine project needs throughout the company.
• Completed independent projects essential to corporate or departmental goals.
• Worked with and assisted senior staff in developing solutions to problems of diverse scope by addressing issues of moderate scope and complexity.
• Rewrote awkward and/or ungrammatical text and addresses poor syntax, whittled down unnecessary verbiage, punctuations. Modified Styles and Formatting.
• Edited, formatted, and managed documentation for submissions with minimal guidance; detected inconsistencies; tracked issues that affect assigned documents.
• Contributed to submissions, presentations; attends submissions working group meetings.
• Coordinated document editing meetings with SMEs, Project Managers, Engineering, and QA
• Use of Word, Excel, Visio, and Livelink document management system.

Technical Writer/Editor/Proofreader

Confidential, Oceanside, CA

Responsibilities:

• Writer and Editor of Book Manuscripts, Cookbooks, Articles, Manuals, College Term Papers.
• Writer/Editor/Proofreader of PhD Dissertations using APA Formatting; Editing/Proofreading of University Term Papers.
• Writer/Editor/Proofreader of Medical Device SOPs, Protocols, Work Instructions, and Product Compliance Validation Documents: EQ/IQ/OQ/PQ1/PQ2.
• Use of MS Word, Excel, FrameMaker, InDesign, Illustrator, Photoshop, Acrobat.

Technical Writer/Senior Proofreader

Confidential, San Diego, CA

Responsibilities:

• Gathered existing Engineering and Manufacturing assembly and test proceduresschematic diagrams, drawings, BOMs, and Engineering and Production personnel.
• Proofread/Edited Manufacturing Assembly/Test Procedures and Travelers.
• Created and modified pictures, graphic charts and drawings for integration with associated text using SolidWorks and Photoshop; MS Office and Adobe applications; Trackwise.
• Adapted sketches and drawings to meet specific technical requirements.
• Created and maintained electronic copies of all documentation.
• Participated in proofreading/editing of documents and communications for co - workers projects.
• Submitted completed documentation to Technical Publications group.

Documentation Specialist

Confidential, Frederick, CO

Responsibilities:

• Hired to assist on - site Documentation Specialist for short-term blood sampler revision project.
• Gathered existing Engineering and Manufacturing assembly and test proceduresschematic diagrams, drawings, BOMs, and Specifications from Engineering and Production.
• Wrote, Proofread, and edited all documentation for new manufacturing project according to Quality Management System Standards and FDA QSR 21 CFR Regulatory Compliance System.
• Created and modified pictures, graphic charts and drawings, illustrations, and maps for integration with associated text; Use of Word, Excel, and Visio.
• Adapted sketches and drawings to meet specific technical requirements.

Technical Writer/Quality Engineer

Confidential, Richmond, VA

Responsibilities:

• Quality Management Audit of Class 3 Medical Device for Premature born babies in NICU:
• Product and Process Validation: EQ/IQ/OQ/PQ1/PQ2 of Development Lab Assembly and Test Equipment; ISO 9000/13485/10555 ; Protocols, SOPS, FMEA/Risk Analysis.
• Researched and compiled Technical information by analyzing Engineering specifications and interviewing hardware and software Engineers, users, developers, and testers.
• Provided feedback to Engineering regarding electronic design changes to product Functionality.
• Wrote, edited, and completed documentation in accordance with FDA QSR 21 CFR Regulatory
• Compliance Management System guidelines and regulations: GDP, GMP, GLP.
• Created and modified pictures, graphic charts, drawings, and illustrations, for integration with associated text. Adapted sketches and drawings to meet specific technical requirements.
• Use of Microsoft Word, Excel, PDF, Paint, Hypersnap, Visio, and Outlook.
• Proofread, restructured, and updated existing documentation by adding new content from Electronic and Software change orders and observations.
• Use of Word, Excel, Outlook, Visio, SolidWorks, Photoshop, and Photoshop.

Technical Writer/ Quality Engineer

Confidential, Boston, MA

Responsibilities:

• Development and writing of Test Method Validation Protocols and Test Method Procedures.
• Validation for existing Cardiovascular Medical Products as part of FDA Recertification;
• Product Validation: EQ/IQ/OQ/PQ1/PQ2; Gage RR; Batch Records of various products (Stents and other invasive devices) for review by Engineering and submittal to Document/QA Control.
• Use of Word, Excel, Outlook, and Photoshop.

Technical Writer

Confidential, Fort Collins, CO

Responsibilities:

• Wrote, Edited, and Tested Process Validation Documents: EQ/IQ, OQ, PQ1, PQ2) utilizing PLM
• Use Case Software tools Matrix One Application Developer and Optimal Trace for client Ortho-Clinical Diagnostics.
• Gathered URS for several PLM software applications (Document Change, CAPA, Product Development Process) & documented those requirements for Testing/Validation.
• Use of Word, Excel, Optimal Trace, and Matrix One PLM Application Developer.