Customer Service Medical Device
Resume:
Susan Garcia
Poway, California 92064
***********@*******.***
PROFESSIONAL EXPERIENCE
Abbott Vascular, Temecula, CA
Sr. Technical Writer / Business Analyst (Contractor), May 2009 – December 2009
• Collaborating with regulatory compliance specialists and internal subject matter experts,
developed and updated global IT corporate policies and procedures. This large-scale,
global SDLC project was a successful effort to streamline documentation and assist
employees with requirements, making them easier to follow and ensuring improved overall
quality assurance.
• As part of the streamline documentation project, solicited and coordinated input, reviews,
and document versioning across multiple time zones for submittal and release through
Document Control for Intranet website.
• Performed research and validation of changing FDA, GAMP, and ISO industry regulatory
controls.
CareFusion (formerly of Cardinal Health), San Diego, CA
SAP Business Analyst (Contractor), January 2009 – May 2009
• As part of the Customer Advocacy team for the Infusion Products Division, updated
regulatory compliance documentation for software programs used for trending and
customer service analysis.
• Assisted in the design and administration of rights and controls for internal SharePoint
customer website.
• Created and distributed data request reports for internal customers.
• Provided research of regulatory updates and trends for the medical device industry.
Abbott Vascular, Temecula, CA
Technical Writer (Contractor), February 2007 – December 2008
• Developed and tracked SDLC regulatory compliance documentation for the global SAP
group. These documents included but were not limited to:
• Requirements Specifications
• Project Planning
• Configuration Management
• Hazard / Risk Analysis
• Design; and
• Testing Reports
• Worked with project managers and software quality analysts to ensure timeliness and
regulatory compliance of all software development life cycle documentation. Used
Microsoft Visual SourceSafe database for file storage and retrieval.
Susan Garcia
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• Developed presentations, training materials, and engineering documents using Microsoft
Word, PowerPoint and Visio. Conducted Net Meetings with international and internal end
users to track and complete projects.
MTS Technologies, Inc., San Diego, CA
Technical / Marketing and Proposal Writer, September 2000 – February 2007
• Created and edited engineering reports, statements of work, user manuals, help guides,
and request for Proposal (RFP) responses for DoD (Navy) medical information technology
programs.
• Coordinated input from subject matter experts, software engineers and DoD clients to
develop technical and marketing documentation including appropriate graphic illustrations.
• Utilized writing, editing, and proposal coordination skills to develop large-scale multi-million
dollar RFP responses.
• Assisted Naval Health Research Center in San Diego in researching and editing academic
publications.
Mallinckrodt, Inc., (formerly Nellcor Puritan Bennett) Carlsbad, CA
Marketing Assistant, November 1995 – August 2000
• Managed and wrote RFP responses and fulfilled pricing and information requests for a
clinical information systems product at an international medical device company.
• Collaborated with national sales force of over 500 reps to generate quotations and provide
contract administration services.
• Coordinated and attended trade shows and client user groups nationwide.
• Worked with marketing communications department to develop sales promotional
materials and developed quarterly product/user newsletter.
Radiation Oncology Computer Systems
Technical Writer, June 1994 – August 1995
• Coordinated, developed, and edited user and physics manuals for FDA-regulated radiation
oncology (brachytherapy) software program.
• Coordinated engineering change requests.
SOFTWARE SKILLS
Microsoft® Word, Excel, PowerPoint, Access, Visual SourceSafe, Visio, Project, and SharePoint.
Windows NetMeeting. Adobe® Frame Maker, Illustrator, Photoshop, In Design, and Acrobat.
Objected-Oriented Design, Telelogic Change, Documentum, and SAP.
EDUCATION
University of Phoenix, San Diego, CA
Bachelor of Science, Business Management
Fluent in German.
Contact this candidate