SUMMARY

• Skilled in medical device written materials, mechanical and electrical fields.
• Researched and developed all engineering documentation from Design Input through Design Transfer.
• Detail oriented, problem solver, enjoy challenges, conscientious, efficient / simplify tasks, flexible and work in a variety of departments, if necessary, to reduce company expenses.

TECHNICAL SKILLS

• Adobe Acrobat DC
• Adobe Dreamweaver CC
• Adobe FrameMaker
• Adobe Illustrator CC
• Adobe InDesign CC
• Adobe PageMaker
• Adobe Photoshop CC
• Adobe RoboHelp
• Autodesk AutoCAD
• Confidential - Docs
• Firmware Testing Software
• Microsoft Dynamics CRM 2011
• Microsoft Office Professional
• Microsoft Project
• Microsoft SharePoint
• Microsoft Visio
• Minitab/Six Sigma
• Oracle Agile
• SAP
• SolidWorks
• Techsmith Snag-It
• Windchill
• Xerox Documentum
• 21 CFR 801/Labeling
• 21 CFR 803/MDR
• 21 CFR 807
• 21 CFR 809/In Vitro
• 21 CFR 820
• 93/42/EEC/Software
• 98/79/EC/Software
• ANSI Z80.7:2002
• ANSI/AAMI 11135
• ASTM Packaging
• Cal OSHA
• cGDP
• cGLP
• cGMP
• CLIA/CLSI
• EN ISO 10993
• FDA/QSR
• HIPPA
• IEC 60601-1
• IEC 60601-1-1
• IEC 60601-1-2
• IEC 60601-1-4
• IEC 60601-1-6
• IEC 62304/Software

PROFESSIONAL EXPERIENCE

Technical Writer, Quality Engineering

Confidential, Irvine, California

Responsibilities:

• Use Adobe Dreamweaver CC for Web edit and design for on-line User Help Manual
• Create, Edit, Revise all Design Control documentation for medical division
• Revise Test Engineering Policies for current projects
• Create SDLC documents, forms, Protocols, Reports for medical division
• Research Requirements for Software implementation medical & non-medical

Technical Writer

Confidential - Irvine, California

Responsibilities:

• Create, Edit, Revise all documentation associated wif Apollo Project when requested
• Create, Edit, and Revise all engineering documentation as requested.
• Work wif SMEs for detailed requirements in associated documentation

Technical Writer, Quality Engineering

Confidential, Yorba Linda, California

Responsibilities:

• Provide Audit Gap Analysis and Conformity Plan for company conformance and Regulatory compliance
• Create new SOPs Confidential ased on Audit findings
• Create Employee Training plan and Training TEMPEffectiveness monitoring for new SOPs.
• Revise all company documentation and Quality System corporate structure processes for Regulatory compliance

Technical Writer

Confidential, Orange, California

Responsibilities:

• Write and Develop Procedures from Federal requirements for Nevada Health Care Systems & Infrastructure Configuration wif use of SDLC requirements
• Write Operational and Maintenance Procedures for Nevada Health Care computer systems
• Source Federal Requirements and Subject Matter Experts for Technical Input to computer systems

Quality Engineer, Technical Writer

Confidential, Ontario, California

Responsibilities:

• Conducted Design Control meetings for acknowledgement and Design Phase sign-off
• Assisted in troubleshooting manufacturing machinery issues wif co-workers
• Conducted Risk Analysis for new products

Technical Writer, Quality Engineering

Confidential, Lake Forest, California

Responsibilities:

• Wrote and performed Manufacturing Audits
• Wrote Test Method Verification and Validation processes and reports, Process Instructions, and Equipment Operation Instructions
• Updated Engineering Drawings
• Created graphics and layouts for Marketing materials and System Operator’s Manuals

Technical Writer

Confidential - Irvine, California

Responsibilities:

• Operated machinery to complement creation of operational instructions
• Used Confidential .Docs for creating, tracking, updating and revising all engineering documentation
• Developed individual machinery operation process flowcharts for complete systems automation
• Created in-depth graphic design product logo for company project use

Technical Writer

Confidential - Irvine, California

Responsibilities:

• Wrote and executed manufacturing audits, process instructions, and equipment operation instructions
• Wrote Test Method Verification and Validation processes and reports
• Developed product labels, IFUs and electronics test instructions
• Used Windchill for tracking, updating and revising engineering documentation
• Developed Quality Assurance procedures for RF Generator testing

Technical Writer

Confidential - Northridge, California

Responsibilities:

• Used SolidWorks and AutoCAD 2010 for drawing revisions
• Created Graphics and Illustrations for computer automated processes
• Used SAP documentation database for all company documentation
• Worked wif Manufacturing and R&D Engineering to create applicable project documentation

Technical Writer

Confidential - Irvine, California

Responsibilities:

• Performed Design Planning in Microsoft Project
• Restructured Company Risk Management for Class III Medical Device from IEC-812 FMECA to ISO 14971:2007
• Created Risk Management process Training Guides
• Developed new Risk Management Work Instructions for creation of the company Risk Management structure and compliance
• Assisted Manufacturing Engineering staff wif processes and procedures for upcoming projects
• Worked wif Quality Assurance in CAPA research and specific documentation related to product development
• Assisted Clinical and Regulatory on Clinical Risk Assessment worksheets
• Worked wif R&D Engineering on scheduled projects