Quality Assurance

2 weeks ago

Sydney, New South Wales, Australia GN Group Full time $90,000 - $120,000 per year

Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you

We're on the lookout for a
Quality Assurance & Regulatory Affairs Associate
to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system – while helping improve lives through advanced hearing solutions.

As our QA/RA Associate, you'll:

  • Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
  • Support compliance with ISO13485 and local regulatory standards.
  • Act as the local 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 corporate 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.
  • Be a key player in a high-performing, values-led QA/RA team.

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 3+ years' experience in a QA/RA role, ideally in medical devices.
  • Is a natural problem-solver and thrives in a process-driven environment.

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