Description
Broad and deep experiences creating Quality Management Systems, implementing, and managing. Regulatory, accreditation SME representing business during inspections, ISO 9001 and 13485 trained, Six Sigma Green Belt, lead auditor, Lean management instructor, Software validation quality representative, Documentation manager, authors and edits policies and procedures at all levels, Strong technical background with Biomedical technologies service
Accomplishments
Highlights:
Six Sigma Green Belt Lead Leadership Healthcare Hero Award Customer award for leadership during external inspection
Job Skills
| Lean Instructor |  |
| Regulatory Standards SME | |
| MS Excel Mastery - Analyzing Data | |
| Author and Edit Policies and Procedures - All Levels | |
| Managing Operations Teams - Matrixed and Typical | |
Keywords
Responsibilities
Created complete Quality Management System for General Electric start up program.
Implemented ISO 9001 and 13485 certification. Retained certification with only minimal recommendations each year.
Go to person for "hot" customers. Save four corporate accounts in 2013.
Led efforts in resolving FDA 483 issues resulting in return to normal business.
