Ambitious, reliable and resourceful Technical Writing / Quality Assurance Professional with 17 years experience supporting product development and quality initiatives for diverse Medical Device Manufacturers and Healthcare Industries and Software and Engineering Service organizations, such as ICU Medical, Becton Dickinson, REDGEAR/TaxWorks and Fresenius Medical Care. Broad expertise spans software quality assurance, product management / support. Demonstrated business acumen with ability to accurately assess technical challenges and transform creative ideas into workable solutions. Strong team leader, adept at training and motivating others to exceed goals with a focus on Human Resource management and Subject Matter Expert (SME) with exceptional ability to research, analyze and translate complex technical information to end - users at all levels. Productive contributor to team efforts; successfully delivered multiple/concurrent projects under the tightest deadlines, within existing and frequently-changing company budget constraints.
- Platforms: MS Windows 7; Microsoft Windows Vista/2003 Server/XP/2000/NT/98/95/3.1
- Networking:, DS, DNS, WI-Fi, Routers, Firewalls, Switches, Appliances
- Software: SAP, MS Office Suite (Word, Power Point, Excel, Access), Lotus Notes, WordPerfect, Norton / MacAfee AV, Adobe Photoshop, Author-it, Framemaker, Captivate, Adobe Acrobat, Robohelp
- Internet Explorer, Clarity, Lotus Notes, TeleLogic, Remedy, Perforce
- Cross-functional Program Participation: HOS: Kaizen, BBS, Standard Work, Visual Management, Andons, Cross training, 5S, cGMP, GLP, FDA, OSHA training.
- Hardware: PC workstations, servers, building, upgrading and supporting IBM compatible components including: CPUs, motherboards, memory, disk sub-systems and tape drives in high availability/data protection environments
- Other: PBX, and hand-held ticket scanners and specialty printers
- Cross-functional Program Participation: HOS: Kaizen, BBS, Standard Operating Procedures and Task Documentation, Visual Management, Lean Manufacturing.
TECHNICAL WRITING & QUALITY ASSURANCE EXPERTISE
Regulatory Affairs Associate - Confidential, Lake City, UT
Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Fully engaged in the active pursuit of continuous education and professional development critical to my role as a regulatory professional. Current with regulatory policies and procedures for one or more countries, as well as maintaining an understanding of the scientific and technical background of healthcare product and medical devices.
- Ensuring that my employer complies with all of the regulations and laws pertaining to the medical device manufacturing industry.
- Working with federal, state, and local regulatory agencies and personnel on specific issues affecting the medical device manufacturing trades; including working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices).
Plant Engineering Technical Writer - Confidential, Sandy, UT
Provide Document Revision and Document control for a campus style network including a MS Windows Active Directory domain running on QDMS / SAP based applications and Win XP workstations, 100 DSL Internet connections and an Sprint Flexicom phone system. Strict adherence to Regulatory Compliance and associated governing bodies; including the FDA, cGMP and OSHA guidelines and regulations.
- Technical / Editorial Revisions and Departmental Control of Engineering Department documentation for electronic and hard copy data storage.
- Streamlined existing documentation to increase functionality and efficiency.
- Performed comprehensive QA review of product documentation.
Engineer of Data Logic Mapping - Confidential, Kaysville, UT
Transfer of design parameter mappings from assorted Tax Preparation Software platforms and Programs into TaxWorks Software. Provide a consistent approach to data extraction, storage, display and manipulation among different data sources. Data transformation utilizing the operational logic of parsing input/output files, extracting and transforming data and maintaining consistency among multiple Tax data sources. Technical Revisions and Departmental Control of TaxWorks Documentation for Conversion Process Releases (Online Revisions).
- Performed comprehensive Quality Assurance review of product documentation.
- Design, modification, and writing of software and hardware documentation, including hardware and software configurations, installation and maintenance procedures, architecture, and end-user support documentation
Lead Technical Writer / Quality Manager - Confidential
Self-employed as a Freelance Technical Writer for several Diagnostic Laboratories and Federally regulated Agencies and Support Divisions throughout Northern Utah. Served as Human Resource Manager / Liaison. Supported corporate migration from non-standardized testing platforms to established FDA, GLP, and OSHA compliant SOP's and TM's. Developed and conducted technical training for internal Associate Technical Writing staff. Tasked with taking point on issues escalated through production team to front-line triage.
- Drove development and growth of Customer Care Department from scratch.
- Product design, development and deployment.
- Oversaw production and building system by installing Windows XP and proprietary Security Metrics software.
- Increased customer satisfaction and customer care team efficiency by implementing new processes, procedures and document revision history database.
Saline Process Technician / Confidential
Provided technical Supervision and Instrument / Equipment maintenance and support for three in-house Quality Assurance / Quality Control laboratories. Performed hardware / software installations, upgrades, troubleshooting diagnostics and preventive maintenance and repair. Planned, authored, edited and executed end-user training for new SOP's and Test Methods. Installed and maintained laboratory software, computer hardware and peripheral equipment for the Dialyzer Research & Development Department and associated laboratories, as well as providing continuous equipment trouble-shooting and issue resolution.
- Supported on-going, in-process training, QA / QC and implementation of production line assembly for saline IV bags prior to production process installation.
- Assisted in the implementation and support of prototype testing and chemical analysis using a High-Pressure Liquid Chromatograph (HPLC) for the isolation of Glucose Degradation Compounds (GDC's) in Peritoneal Dialysis (PD) Solution.
- Designed and validated SOP's and TM's which are still in use today in multiple laboratory environments. Supported "worst-case" scenario and functionality testing of artificial kidneys and components.