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Quality Engineer I at Dentsply Sirona | JobVerse
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Quality Engineer I
Dentsply Sirona
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Quality Engineer I
Costa Rica
Full Time
5 hours ago
H1B Sponsor
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Key skills
R
About this role
Role Overview
Owns and manages the Corrective and Preventive Action (CAPA) program in compliance with FDA QSR/21 CFR 820, ISO 13485, MDSAP, and EU MDR requirements
Monitors changes to external standards and regulations; assess impact and coordinate timely updates to internal procedures and processes
Develops, maintains, and reports quality metrics to evaluate effectiveness of the Quality Management System (QMS)
Ensures all initiatives are compliant with regulatory and legal standards and company policies
Requirements
Bachelor’s degree in engineer or a related discipline
Minimum of 5 years’ experience in Medical Device, Pharma, BioMed or other regulated industry
Experience in FDA Good Manufacturing Practices and/or ISO Quality Management System Requirements
Quality Manager Certification and/or Certified Quality System Auditor is a plus
Microsoft Dynamics AX and TrackWise knowledge preferred
Strong validation knowledge and background
Passport for travel to EEUU and Mexico.
Benefits
Desarrolle más rápido, con nuestro compromiso con el mejor desarrollo profesional.
Mejore su desempeño, como parte de una cultura de alto desempeño y empoderamiento.
Marque la diferencia ayudando a mejorar la salud bucal en todo el mundo.
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