Quality Assurance

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Join to apply for the Quality Assurance & Regulatory Affairs Associate role at GN Group

Quality Assurance & Regulatory Affairs Associate

Join to apply for the Quality Assurance & Regulatory Affairs Associate role at GN Group

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.

Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionLegal
• IndustriesAppliances, Electrical, and Electronics Manufacturing, Medical Equipment Manufacturing, and Computers and Electronics Manufacturing

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