St. Louis, MO
SHELLY
St. Louis, MO
EDUCATION: BS Mechanical Engineering
University of Missouri - Rolla
MBA Keller Graduate School of Management
EXPERIENCE: Anodyne Surgical O’Fallon, MO
Small manufacturer of surgical instruments
Director of QA/RA Aug 2012 – Oct 2013
• Responsible for all aspects of quality and regulatory, including:
o FDA registration
o Technical File maintenance
o Audit program (internal, supplier and 3rd party)
o Quality control (manage 3 FTE’s)
o Quality system (procedures – Doc Control, processes, CAPA, customer complaints, risk analysis - FMEA)
o Responsible for maintaining ISO 13485 registration, CE mark, GMP and good standing with FDA and regulatory bodies world-wide
o Validations
bioMerieux, Inc. 2003 - 2012 Hazelwood, MO
Large manufacturer of medical device instruments and reagents
Associate Staff Quality Engineer Apr 2009 – Aug 2012
• Led internal and supplier audits
• Completed customer surveys and hosted customer audits
• Certified Six Sigma Master Black Belt
• Mentored/coached Green/Black Belt project leaders
• Led scrap reduction and process improvement projects, including Kaizen Blitzes and RCA cross functional teams
• Led a Black Belt project to reduce lot loss due to human error saving $500,000
• CAPA Coordinator (TrackWise and Livelink)
• Prepared and administered training grants with the State of MO
Senior Quality Assurance Engineer Mar 2006 – Mar 2009
• Responsible for all aspects of Internal Audit Program
• Supported and hosted Customer and 3rd party audits
• Led project teams to reduce scrap
• Data analysis and trending for service order data using Minitab
• Reviewed and approved Corrective and Preventive Actions
Quality Assurance Engineer Feb 2003 – Mar 2006
• Led internal and supplier audits
• Investigated and responded to internal & customer complaints
• Supported ISO 9000 registration, FDA and cGMP regulations
• Supported instrument production, scrap reduction, validations
Process Quality Engineer Sept 2000 – Feb 2003
Lear Corporation Bridgeton, MO
Large Tier I supplier for the automotive industry
• Performed internal audits
• Evaluated mfg...
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