Patti Vaitaitis Email and Phone Number

Independent Technical Documentation consultant providing expert guidance to a variety of companies. Satisfied clients include Seismic Software (San Diego, CA), Teradata Corporation (San Diego, CA), Fresenius Medical Care(Lake Forest, CA), Sakura Finetek (Torrance, CA), Advance Clinical (Irvine, CA), Syagen(Tustin, CA), Canon Information Systems (Irvine, CA), PELogic (Yorba Linda, CA), andBeckman Coulter (Brea, CA).

Technical writing and information design for service manuals, user manuals, and software systems used in a variety of products and industries, including medical pathology laboratories.

Coordination, creation, and stewardship of process and procedure documentation to support all aspects of the company, including Security, GDPR compliance, and various operational processes. Experienced with ITIL, ISO, and SOC principles.

Content design and creation for large and complex hardware systems. Documentation deliverables created using DITA (XMetaL) and Content Management (Astoria), in a team-based, collaborative environment.

On contract to a large provider of Big Data and Analytics products. Provided writing support using DITA and Content Management tools.

Created end-user and training documentation for a dialysis system. Position required knowledge of FDA regulations for documentation of Class 2 medical devices, as well as techniques for creation of clear and unambiguous instructions.

Provided documentation support for an in-house, proprietary information management system at a large, Orange County Pharmaceutical company.Also contributed to the Quality System documentation at Advance Clinical.

Responsible for Information Design and Content Development for new product end user and service documentation, implementation of a preliminary DITA strategy, and investigation of a content management system.Previously responsible for management of a staff of 16 publications professionals. Handled day-to-day management decisions including content design and creation for user documentation for numerous product lines. Content is created in English using multiple tools then localized for the global market.Major accomplishments include effectively managing a $1,000,000 translation budget and $2,000,000 department budget. Under my direction, the department met budget goals for the first time, with better than anticipated savings in outside translation costs. Negotiated schedules and budgets for multiple projects, and made numerous process improvements to increase productivity within the department. Participated on numerous "Lean" initiatives, including a project that reduced the approval time for user documentation by six weeks per project. Worked closely with regulatory representatives to ensure that customer documentation met or exceeded FDA and international regulatory requirements, and that change control and compliance mandates were enforced. Refocused the activities and priorities of the department to absorb a 25% increase in workload with flat headcount. Introduced structured authoring and emphasized use of simplified English. Partnered with a major translation vendor to achieve additional productivity improvements.

Supervised a team of senior technical writers to produce a complete set of documentation for the image acquisition software products. Responsible for design and timely production of multiple online help systems and various technical and reference manuals delivered in PDF format with the software. As the primary point of contact for the documentation group, I was responsible for nearly all scheduling and planning activities. In addition, I researched effective documentation strategies by interviewing customers and field personnel, and attended workshops and seminars on user interface design and usability. Additional responsibilities included day-to-day supervisory and management duties such as merit reviews, promotions, and performance mentoring for a staff of senior technical writers. I worked closely with members of other departments in cross-functional and cross-product teams.

Projects included documentation of manufacturing procedures for ISO 9000 compliance, editing corporate policy documents related to ergonomics, and numerous user and reference documents for clinical and laboratory devices.Long-term contract assignment in Technical Operations (Supply Chain) updating manufacturing documents for life science automation and diagnostic systems, and for manufacturing and testing of consumable reagents.