Celeste Amlen
Sr Partner at True Consulting Group, Llc at True Consulting Group, Llc
Based in Irvine, United States
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Seniority
C-Team
Department
General Business & Management
Location
Irvine
Industry
Medical Device
Company size
4
Contact information
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c•••••••@truetcg.com
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Background
About Celeste Amlen
An experienced Quality Executive Professional with over 20 years experience in the Medical Device, Pharmaceuticals and In-Vitro Diagnostics Industries. Quality Assurance leader with international work experience from several Fortune 500 companies. A successful track record in continuously improving performing Quality Assurance organizations. A catalyst for turning around ailing organizations through the implementation of new organizational structures, system implementations as well as execution of business process transformation projects. Extensive experience working in a fast paced, high-energy work environment on high visibility projects, with the last eleven years dedicated to Quality Systems and Project Management in the Medical Device and In-vitro Diagnostics industry. Extensive experience interfacing with the FDA in compliance related matters; facility inspections, responding to FDA 483 and Warning Letters, Medical Device Reporting. Setting up quality systems in conformance to ISO13485 and 21 CFRs. Complaints Management Non-conformances (NCRs) Corrective & Preventive Actions (CAPA) System/Process Validation Audits (External & Internal) Document Management Specialties: FDA QSR / cGMP / 21 CFR Part 11 SO 13485 / ISO 9001/ISO 14971 MDD / CMDR / IVDD Black Belt / Six Sigma Project Management Quality Systems Business Process Engineering Lean / Value Engineering
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