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Specialist Quality Line – Quality Assurance

Dentsply Sirona · Ballaigues

🇬🇧 English
GMP PFMEA CAPA Root Cause Analysis Process Validation Change Control VMP OLM

Job description

About the role

The Specialist Quality Line is responsible for ensuring the highest quality standards on a dental product manufacturing line. You will lead quality emergency situations, manage non‑conformities, and support continuous improvement across the line.

Key responsibilities

  • Ensure compliance with work instructions and conduct regular GMP audits.
  • Manage quality holds, lead root‑cause investigations, and open non‑conformities for recurring issues.
  • Maintain up‑to‑date PFMEA and risk analyses; review and update VMP as needed.
  • Drive CAPA processes for operational quality issues and create quality dashboards with KPI trend analysis.
  • Lead process validation, change control, and support transversal QA initiatives.
  • Coach production team leaders on first‑level investigations and root‑cause analysis.
  • Monitor implementation of process deviations and alert supervisors of any risk.

Required profile

  • Master’s degree in a relevant scientific or engineering discipline.
  • Experience in a manufacturing environment, preferably within medical or dental devices.
  • Strong understanding of GMP, quality systems, and regulatory requirements.

Required skills

  • GMP compliance
  • PFMEA development and maintenance
  • CAPA management
  • Root Cause Analysis
  • Process Validation
  • Change Control procedures
  • VMP (Validation Master Plan) handling
  • OLM (Operational Line Management) dashboard creation

Questions fréquentes

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Published 3 months ago

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Dentsply Sirona

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