Michelle Davis Vargas
Board Member @San Diego County Engineering Council
Signup · Get unlimited contacts
WORK HISTORY
Board Member @San Diego County Engineering Council
San Diego County, CA, US
EDUCATION
STAT-A-MATRIX INSTITUTE
Audit of Quality Management Systems ISO 9000 w/ Medical Device GMP (21 CFR 820) Auditor/Lead Auditor, Pass
San Jose State University
B.S., Industrial & Systems Engineer, Cum Laude Graduate
ASQ
Completion Certificate, ASQ CQE Course, Pass
ASQ
Completion, Certified Quality Auditor Course, Pass
ASQ
Completion, Certified Lean Six Sigma Green Belt Course, Pass
ASQ
Completion, Certified Manager of Quality/Organizational Excellence Course, Pass
SAI Global
Internal Auditor Training for FDA Regulated Industries (ISO 13485:2003 and ISO:9001: 2000), Pass
San Diego State University
Advanced Certificate, Regulatory Affairs, A's in all four Regulatory Affairs courses
Harvard Business School
Harvard Business School Management Development Program, Business Administration and Management, General
ASQ
Completion, Just Statistics for Certified Quality Engineer(CQE) & Certified Six Sigma Black Belt (CSSBB) Course, Pass
Toasmasters International
Member
Virginia Polytechnic Institute and State University Division of Continuing Education
Medical Devices Risk Management Training Using HACCP Principles, Pass
ABOUT MICHELLE DAVIS VARGAS
HIGHLIGHTS OF QUALIFICATIONS +Quality and Compliance Leader with 20+ years of experience in the medical device, pharmaceutical, and aerospace manufacturing industries.+Strong experience in supervising staff in several areas of the Quality System (Quality Management Review, Document Control, Quality Control, Corrective and Preventive Action System, Material Review Board and Non-conformance, Complaint System, Validation Program, Customer Quality, Supplier Quality, Deviations, Change Control, Incoming Quality Control, Receiving Inspection, In-Process Inspection, Final Inspection, GMP Quality Training, etc.)+Strong experience in Quality Systems, Quality Engineering, Validation, Customer Complaints, Corrective and Preventive Actions, Non-conformances, Design Controls, Sampling Plans by Attributes and Variables-ASQ ANSI Z1.4 and Z1.9, Change Order Control, Lean Six Sigma, and Audit (Internal and Supplier) in compliance with the following regulations: FDA 21 CFR 820, ISO 9001:2015, ISO 13485:2016, FDA 21 CFR 210 and 211, 21 CFR 11, and Aerospace standard AS 9100.+Strong experience in these Quality Engineering Tools: Lean Six Sigma, Kaizen, Statistical Process Control (SPC), Sampling Plan, Continuous Improvement, Design of Experiments (DOE), Gage R&R, Risk Assessment (Fault Tree Analysis and Failure Mode & Effect Analysis), Fishbone Diagram, and 5 Whys.+Strong experience in these Quality System Softwares: SmartSolve, MasterControl, ComplianceWire, and Etq.+Strong experience in these Statistical Softwares: Minitab, Statgraphics, and Jump.+Strong experience in these Document Control Softwares: MasterControl, SmartSolve, and SAP.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.