Quality Assurance

19 hours ago

Sydney, New South Wales, Australia Gn Group Full time

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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