SUMMARY:

• Technical writer/Trainer /QA in various medical device, bio - pharma and high tech companies since 1983
• Skills in and content management system for various end-users: technical, non-technical and customer support
• Skills in information mapping and instructional design for synthesizing complex information into usable documentation
• Skills and knowledge to deliver various documents and templates: Framemaker, MS Word, Acrobat, MS Excel, MS PowerPoint, Illustrator, Photoshop, Visio, RoboHELP HTML 8, Dreamweaver, Livelink, Sharepoint, Oracle-based Applications, Captivate, Help files, Wiki, Online Help, Salesforce, Captivate, Lectora, Wiki, PlantUML, Assembla, Acrobat, HIPAA (since 1994 with medical device/biopharma), SOX (Philipps Healthcare),DITA, XML, API, networking, Agile,Customer Service app, Relational databases, procedure writing, JAVA, Adobe InDesign and Adobe illustrator
• Skills in SPC, InfinityQS SPC and other applications
• Skills in GMP environment for medical device and biopharma since 1996, includes Design Control and Document Control
• Delivered software application using Webex (Pandora data systems)
• InfinityQS admin and trainer for Zimmer
• Wrote RFP, RTR, SOPs, study protocols, validation reports, ERP-Financial related requirements specification and assembly/test work instructions using Word since 1994 ( Lifescan, Confidential, Roche, Confidential, Celera Diagnostics, Philipps IT Healthcare, Nike IT, Confidential )
• Wrote APIs, software test plans, proposals and reports for ABB
• Wrote CAPA, risk assessments and product investigation reports for Varian, Confidential and Confidential
• Wrote User's manual and technical documents for Nike IT, Philips Healthcare IT and Confidential
• Taught pharmacy technician course at SVC and Bryman College
• Authored Material Safety Data Sheet (MSDS) for Confidential, Fremont (IVD products)
• Knowledge of Java, Python, XML, HTML and C++ programming, 21 CFR Part 11 and Part 820
• Passion for, been a teacher for 1 yr, 3 yrs as trainer at Intel, technical writer since 1989
• Collaborated with SMEs in designing technical documents and materials
• Editor for Confidential 's department
• Technical trainer for Intel
• Test engineer for Acer

PROFESSIONAL EXPERIENCE:

Confidential, Santa Clara CA

Data Scientist

Responsibilities:

• Analyze data, find trends and recommend strategies and solutions

Confidential, Redwood City, CA

Technical Writer

Responsibilities:

• Wrote requirements documents, test protocols, SOPs and process mapping
• Uses Assembla, Wiki, Plant UML and Word in documentation
• Wrote, edited and formatted materials for customer service and end-users
• Developed materials online for use by customer service in end-users of Drupal
• Wrote Wordpress blog for technical
• Wrote Software developer’s guide
• Delivered for customer service and other power users on the use of Drupal and Wordpress

Confidential, Santa Clara, CA

Technical Writer/QA

Responsibilities:

• Wrote requirements documents, test protocols, CERs, SOPs and process mapping
• Identified and documented gaps for CAPA, complaints
• Created and modified flow charts for technical documents using Visio
• Created and modified templates, style guides and SOPs
• Wrote ERP-Financial related requirements specification

Confidential

Technical Writer

Responsibilities:

• Wrote test protocols, study reports and other technical documents for Device Dev dept
• Worked with SME in getting content for product
• Created and modified flow charts for technical documents using Visio

Confidential, Fremont, CA

Technical Writer/MSDS Author

Responsibilities:

• Wrote MSDS SOP/templates and updated 500 MSDS
• Wrote requirements specifications, CERs and performed gap analysis
• Used Agile for managing the documents.
• Maintained records, managed technical writers and formatted documents
• Created and modified flow charts for technical documents using Visio

Confidential, Burlingame, CA

Document Control/QA

Responsibilities:

• Wrote CERs, materials, SOPs, forms and financial reports using MS Excel, Word, and PowerPoint
• Wrote CAPA, risk assessments and product investigation reports
• Developed forms and reports using MS Excel and Word
• Collaborated with supplier in closing CAPAs, identifying root causes and assisting in the planning of corrective and preventive actions, finding process gaps
• Leveraged CAPA investigations to find solutions for purchasing, customer service and the company’s bottom line
• Conducted product complaints investigations
• Trained the whole company in Quality Tools such as Statistical Quality Control, and other data analysis, root cause analysis, quality processes, gap identification, workflow simplification and process improvements
• Wrote Quality Manual, MDR, CAPA and CAR forms, procedures and templates and validation test protocols/reports to establish quality system
• Responsible for all medical device reporting, CAPA coordination, and quality audits in compliance with QSR and other regulatory standards
• Assisted management in implementing the QMS to improve current process and reduce customer complaints
• Maintained records, managed technical writers and formatted documents
• Created and modified flow charts for technical documents using Visio
• Wrote ERP-Financial related requirements specification

Confidential, San Mateo, CA

Technical Writer

Responsibilities:

• Wrote test protocols, specifications, program plans and SOPs
• Used Livelink and SharePoint as document management system
• Created and modified flow charts for technical documents using Visio
• Wrote ERP-Financial related requirements specification

Confidential, San Jose, CA

Document Control/QA

Responsibilities:

• Conducted product complaints investigations
• Wrote CERs, QA manual, SOPs, Forms and validation test protocols
• Wrote CAPA, risk assessments and product investigation reports
• Performs QA functions from writing SOPs, measuring quality, CAPA and MDR coordination and and preparation for CE submission
• Drafted Templates for all documentations from customer requirements to test protocols
• Identified needed regulatory requirements for the software portion of the product in preparation for CE compliance
• Maintained records, managed technical writers and formatted documents
• Created and modified flow charts for technical documents using Visio

Confidential, San Jose, CA

QA Specialist

Responsibilities:

• Prepared the software product for CE submission by preparing all templates from customer requirements, Software System Specs to test protocols with traceability and risk management element
• Created and modified CERs and other technical documentation for quality, regulatory and marketing

Confidential

Technical Writer

Responsibilities:

• Responsible for drafting, editing and maintaining technical documents for the organization
• Created and modified flow charts for technical documents using Visio
• Used Captivate in elearning related documentation

Confidential, Pleasanton, CA

Technical Writer

Responsibilities:

• Wrote System Validation reports/protocols and supported RA/QA for 510k submission documents

Confidential, San Jose, CA

Pharmacy Technician Instructor

Responsibilities:

• Taught pharmacy technician course

Confidential, San Jose, CA

Technical Writer

Responsibilities:

• Wrote 70 study protocol reports
• Participated in Six Sigma Quality

Confidential, San Jose, CA

Technical Writer

Responsibilities:

• Participated in the testing of Confidential Document (eDMS) and Process management system
• Wrote press releases, technical support documents, materials, User’s Manual, Manual for Document Change Management system. Handled customer complaints and product deviations. Performed internal QA audits.
• Supervised 1 Customer Support Specialist and 1 technical writer.
• Tested the software product and performed other software QA functions

Confidential, San Jose, CA

Technical Writer

Responsibilities:

• Responsible for making sure that all Information Systems documents/Software Functional Specifications comply with Quality System Regulations for Medical Devices
• Wrote System and Software Detailed Design Description documents

Confidential

Programmer/Trainer

Responsibilities:

• Programmed in Cobol, Basic, Dbase all manufacturing related data metrics from Finance to Manufacturing
• Taught all executive personnel on use of Excel and DBase