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SUMMARY STATEMENT
Dedicated, detail-oriented quality engineer with extensive knowledge of chemistry, biology, and engineering who is effective at communicating at many levels. Engineering experiences along with my work ethic have demonstrated resourcefulness, consistency, and self-motivation. Manufacturing experiences have established an ambitious group leader enthusiastic to contribute the effort into getting the tasks accomplished, improving quality, and eliminating wastes.
EDUCATION
Sept 2000- May 2005
University of Massachusetts- Amherst, MA
Bachelor of Science in Chemical Engineering (Minors in Psychology and Math)
Jan 2007- Dec 2010
University of Colorado- Boulder, CO
Master of Engineering in Engineering Management (Concentration on Quality Systems/Engineering)
Black Belt in Six Sigma
PROFESSIONAL EXPERIENCE
Dec. 2009- Current
Quality Assurance Engineer/ Quality Supervisor
Angiotech Pharmaceuticals Gainesville, FL
> Supervisor of all quality technicians
> Update inspection sheets/ procedures/ material specifications to make improvements, ensuring we are compliant with FDA and ISO requirements (i.e. ISO 13485, ISO 14644, ISO 14698, ISO 11137)
> Work with investigations for non-comformances and CAPAs.
> With development engineers and manufacturing engineers, manage new products or improvements to existing products
> Assist with complaints related investigations
> Lead efforts for compliance of environmental monitoring, bioburden, and calibrations based on ISO regulations
> Provide leadership with supplier/customer complaints and/or specification changes
> Self initiated biomedical waste project for cost savings of approximately $16,000/year
Oct. 2007- Dec. 2009
Process Engineer (Quality Engineer /Material Control Planner)
RTI Biologics Alachua, FL
> Problem- solve/trouble-shoot issues with manufacturing processes and equipment involving bovine tissue release, processing, sterilization, and packaging
> Update SOPs according to changes in manufacturing processes, materials, and equipment
> Investigate and submit NCR’s/ CAPA’s in the bovine business unit and put items on QC hold when needed
> Coordinate and finalize quality cell shutdowns in the bovine business unit
> Submit and execute IQ/OQ/PQ for new equipment in the business unit
> Led the business unit’s facility cleaning validation
> Perform functions of QRB
> Initiate Process Monitoring Improvement efforts
> Participate in complaints investigations
> Plan and organize the workload to meet production and delivery to customers
June 2006- Aug 2007
Process Engineer
Vermont Circuits Brattleboro, VT
> In charge of laboratory procedures, supervising and training laboratory personnel, and creating standard operating procedures and process control manuals for proper operation of equipment following QSR Manual.
> Problem-solve/trouble-shoot dilemmas or issues with manufacturing processes, equipment, and chemical baths.
> Ensure proper safety procedures are demonstrated and followed.
> Assist the process engineer manager in implementing manufacturing processes and equipment.
> In charge of maintaining laboratory materials, implementing new computer programs for process control, and analyzing chemical baths for the manufacturing plant.
> Optimize processes for cost reduction. Maintain cost analysis spreadsheets to keep records of effective cost reducing changes. Reduced cost of the electro-less plating line by 20%.
> Part of TEAMS, a group of 8, implementing improvements to reduce scrap costs for one department by 75%.
> In charge of a de-ionized and reverse osmosis water project that will save the company more th...
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