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.