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Regional Quality Head

Healthcare Professionals Group · Sydney

Senior 🇬🇧 English
CAPA

Job description

About the role

The Regional Quality Head will lead the unified quality and compliance strategy for the International East region within a global medical‑device/healthcare organisation. Reporting to Global Quality leadership, you will partner with senior executives to harmonise quality practices, accelerate execution and raise standards across multiple markets.

Key responsibilities

  • Define and implement the regional quality and compliance strategy.
  • Act as the senior quality partner to regional leadership and executive stakeholders.
  • Standardise quality approaches across markets, replacing fragmented local processes.
  • Oversee quality systems to ensure ISO 13485 compliance.
  • Lead regional CAPA and escalation processes to resolve systemic issues.
  • Collaborate with R&D, Operations, Supply Chain and Commercial teams.
  • Monitor and improve supplier, distributor and contract‑manufacturer quality performance.
  • Drive continuous‑improvement and cultural‑transformation initiatives.
  • Build, lead and develop a high‑performing regional quality team.
  • Represent the region with global quality, regulators and external stakeholders.

Required profile

  • Degree in Science, Engineering or a related discipline.
  • Extensive quality experience in medical‑device, pharma or related industries.
  • Strong knowledge of ISO 13485 and CAPA processes.
  • Proven leadership of large, cross‑regional teams.
  • Ability to influence senior stakeholders and drive strategic change.
  • Excellent communication skills and ability to simplify complex issues.
  • Experience working across multiple geographies and regulatory environments.

Required skills

  • ISO 13485 compliance
  • CAPA management
  • Quality Management System (QMS) implementation
  • Supplier and distributor quality oversight

What we offer

  • Leadership role with regional influence
  • Opportunity to work with a high‑performing global organisation
  • Drive strategy, transformation and change across multiple markets

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Published 2 months ago

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Healthcare Professionals Group

Sydney