Dentsply Sirona

Quality Engineer I

Dentsply Sirona

full-time

Posted on:

Location Type: Hybrid

Location: Costa Rica

Visit company website

Explore more

✨ AI Apply
Apply

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Corrective and Preventive Action (CAPA)Quality Management System (QMS)FDA Good Manufacturing PracticesISO 13485MDSAPEU MDRquality metricsvalidation knowledge
Certifications
Quality Manager CertificationCertified Quality System Auditor