Verified recordBiotechnology Research

Terri Simpler

Director of Quality at Thermo Fisher Scientific

Based in San Francisco, United States

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Seniority

Director

Department

General Business & Management

Location

San Francisco

Industry

Biotechnology Research

Company size

99K

Contact information

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t•••••••@thermofisher.com

Phone

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Background

About Terri Simpler

Key Areas of Expertise - ISO 9001:2015 auditor - ISO 13485:2015 Auditor - 21 CFR part 820 - Risk Assessment - EMC and Safety compliance - RoHS compliance - IHS/GLP compliance for SDSs - Six Sigma, LEAN, PPI - QMS Acquisition/Divestiture/Integration - QMS programs (CAPA, Audit, Calibration, Training)- Customer Audits - FDA inspection (CDRH governed lasers - Doc control/change control - Business Process Development - Product Quality troubleshooting processes - Warranty reduction management - Product quality improvements - 10+ years leading teams, direct & indirect - Product Development Lifecycle - Cross functional collaboration - Strong people manager and mentor - Organizational Capability Assessments - Training Development and Management

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