Quality Assurance Manager

2 days ago


Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $130,000
Job Summary:

This is an exciting opportunity to lead day-to-day quality assurance and regulatory affairs functions for Australia, New Zealand, and affiliates. The successful candidate will support compliance with ISO 13485 and local regulatory standards.

About the Role:

  • Lead quality assurance and regulatory affairs functions for ANZ operations.
  • Support compliance with ISO 13485 and local regulatory standards.
  • Act as subject matter expert for quality processes and risk assessments.
  • Conduct internal audits and manage CAPAs, NCs, and quality records.
  • Drive validation activities for custom-manufactured products at our Sydney facility.
  • Collaborate with internal teams and stakeholders across the globe.
  • Train and support teams on quality and regulatory matters.
  • Represent the business in local QA/RA meetings and interactions with TGA and other bodies.

We're Looking For Someone Who:

  • Has a solid understanding of ISO 13485 and quality systems.
  • Knows their way around internal auditing, CAPA, and validation processes.
  • Is confident, detail-oriented, and self-motivated.
  • Communicates effectively with stakeholders at all levels.
  • Has experience in a QA/RA role, ideally in medical devices.
  • Is a natural problem-solver and thrives in a process-driven environment.

Key Responsibilities:

  • Manage quality processes and risk assessments.
  • Conduct internal audits and manage CAPAs, NCs, and quality records.
  • Drive validation activities for custom-manufactured products.

What You'll Bring:

  • Experience in a QA/RA role, ideally in medical devices.
  • Knowledge of ISO 13485 and quality systems.
  • Excellent communication and stakeholder management skills.
  • A natural problem-solving ability.


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