Mike Ornelas
Senior Director, Quality Systems @Cepheid
San Jose, CA, US
EMAILS
m••••••••@cepheid.com
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Mar 2022 — Present
Senior Director, Quality Systems @Cepheid
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Sunnyvale, CA, US
Provides management Global strategic direction and operational coordination of activities to ensure compliance with FDA, ISO, and other applicable global regulatory requirements as well as alignment with company objectives and Quality Standards. Direct Sunnyvale responsibility and Global oversight for Quality System processes including CAPA, Internal Audits, Learning and Development, Document Control, and Product Safety & Environmental Compliance.
SKILLS
Quality ControlSopIso 13485Quality SystemSupplier QualityManufacturingProduct DevelopmentQuality AssuranceFdaMedical DevicesCapaGmpV&VFda Gmp21 Cfr Part 11BiotechnologyValidation
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