20 + years of progressive experience within the medical device, automotive, telecommunication and semiconductor environments delivering innovative solutions to realign underperforming areas. Led 3 companies to ISO and QS certification and retention of their registration status

TYPE	TITLE	URL	DESCRIPTION
Book	BRAG! Tooting your own horn witout blowing it	media url	30 Second speech

Highlights:

 Championed and installed state of the art software management system for Design History Reports.  Reduced backlog by 30% within 4 months through the facilitation of archive training.  Created SOPs and flowcharts and provided training that led to quantified acceptance of product at inspection. Developed and implemented marketing documentation Major contributor to complaint remediation and determination of MDR submission as a result of FDA Warning Letter, and FDA 21 CFR Part-803, Medical Device Reporting

Companies I like:

Companies that deal with medical devices, telecommunications, SemiconductorAutomotive

• Document Control Analyst
• ISO quality systems implementation and maintenance
• CAPA
• Record Retention
• Training
• Quality Asurance Specialist
• Record Retention & Achival

Oversaw CAPA projects for this modulation business division of St. Jude Medical Developed and implemented marketing documentation including designing brochures, procedures and process mapping for Renewable Energy and Educational Consulting companies. Managed technical writing, editing, proofreading, document design and layout. Assisted and resolved CAPAs as a result of a FDA warning letter. Managed complex documentation projects through methodical planning and constant coordination with stakeholders and Subject Matter Experts. ISO and QS implementation. Supported Sustaining Engineering and CAPA Owners and identified root causes.