Terri Simpler
Director Of Quality at Thermo Fisher Scientific
- Role
- Director of Quality at Thermo Fisher Scientific
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
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
Experience
Director of Quality
Feb 2019 — Present · Santa Clara, US
Quality Site Lead for Bioprocessing Equipment and Automation (formerly known as Finesse)- building quality & product compliance team to meet high growth Thermo Fisher structure and requirements - establishing ISO Quality system certification and quality fundamentals in organization - expanded role to multisite quality functions in 3 sites - management rep responsibilities
Education
Santa Clara University Leavey School of Business
Master of Business Administration - MBA, Business Administration and Management, General
Angelo State University
BS, Chemistry,Microbiology
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