Quality Assurance Control
Resume:
Deborah Hand
Racine, Wisconsin *****
phone: 262-***-**** (cell)
***********@*******.***
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PROFESSIONAL EXPERIENCE
BioForm Medical, Inc (Jan 2007 - Nov 2008) Medical Device Manufacturer
Quality Engineer / Responsibilities: Quality Assurance; Complete process
validation(s) of new or updated equipment to include it's process used in
product development through final product review by written IQ/OQ/PQ
(Protocols and Reports), FMEA, (Failure Mode Effectivity Analysis), Risk
Assessments; and Impact Analysis reports for Regulatory FDA submissions and
overall compliance; Supplier Audits and Capability Studies; and Quarterly
Internal Audits Auditor.
o Participates on Project Team as Quality Representative. Ensures
principals of Design Control are applied to Product and Process
Changes and New Product Development.
o Create, review, update and verify protocols (reports: IQ/OQ
/PQ; Validation Reports; FMEA; Clinical Studies)
o Performs internal audits ~Completion of Audit Reports &
Corrective Action Assignment
o Performs supplier / vendor audits (including supplier capability
studies to verify compliance with applicable registrars)
o Creates and maintains control charts for key performance
indications to include action assignments.
o Facilitates and reports key performance indicators (KPI) and
process control charts in bi-monthly quality improvement meetings
and monthly management review meetings.
o Continuous interaction with quality control and manufacturing
for optimal process performance.
Bossard (2004 to 2006) Global Fastener Distributor (industry)
Account Manager
o Complete support and absolute insurance of quality parts - measured by
monthly scorecard reports and control charts using PPMs and current
IFI standards.
o Implementation of quality control processes for smooth production flow
of parts.
o Identification of production flow need, negotiations of cost for
parts, and maintain a budget of zero dollars for excess inventory.
o Review of contracts, blanket orders and / or individual impromptu
production needs.
o Proper execution of design or engineered changes for purchased parts
through Bossard.
o Continuous "on-site" support for value stream mapping and
implementation
ACMI Corporation (2000-2004) Manufacturer of Electromechanical Medical
Devices
Quality Analyst- Product analysis & manipulation of raw data converted from
spreadsheets to graphs & PowerPoint Presentations. Facilitator of weekly &
monthly management review meetings. Preparation and maintenance of:
o Nonconforming material/products including investigation analysis &
validation testing.
o Corrective Action (CAPA) materials to include all trend analysis,
supplier actions, internal quality metrics supporting spreadsheets
using pare do analysis methodology.
o Recorded and reported all inspection criteria - key areas needing
analysis weekly, monthly & quarterly to include assignments all
actions.
o Represented the Quality Assurance / Engineering departments during
Company Material Review Board meetings.
Lacrosse Rainfair Safety (1999-2000) Manufacturing Firetech Boots - Danner
- Industrial Safety Products
Business Analyst (position) - Development of all internal procedure to
include:
o Control quality issues resulting in product returns or customer
complaints
o Instructed / Trained personnel new computer hardware and software
programs
o Managed market strategies of industrial products
o Maintenance & data integrity of customer master data files
o Implemented process flow resolutions, by writing needed policies and
procedures.
CERTIFICATION - POST EDUCATION CERTIFICATES / TRAINING
o Validation Principles & Sampling Plans Certification ~ May 2008
o CQA = Certified Quality Auditor ~ Recertification Test Dec 2008
o Six Sigma Quality Process Controls - Green Belt Certification, 2002
o APICS Certified 1997;
EDUCATION
Radford University, Radford, VA - Bachelors Degree, 1996 - Business
F I T, NY, NY - Fabrication of Textiles - Associates Degree / Textile
Fabrication
Military Service - Active Duty
United States Air Force ~ Active Duty Service 1985 - 1992
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