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QA & RA Associate

GN Hearing Australia Pty Ltd
North Ryde, NSW
A$100,000-$110,000 p/a
Healthcare & Medical → Pharmaceuticals & Medical Devices
Full-time
On-site

Posted 14 days ago


GN is a Danish multinational company that operates in the healthcare and technology industries. Known for its innovative products (with brands such as: Jabra, SteelSeries, BlueParrott, GN Hearing (Beltone, ReSound) that aim to improve people's lives by enhancing communication and hearing experiences.

For 150 years the people of GN have been driven by a shared purpose to make life sound better. Our pioneering spirit has made us a global leader in intelligent audio solutions, transforming lives through the power of sound. As our business grows, we constantly seek fresh opportunities to deliver against this vision, addressing new and existing markets with our portfolio of carefully positioned brands.

About the Role

At GN Hearing, the leading hearing aid company in the AU market, we believe in transforming lives every day. If you're driven by curiosity, thrive in hands-on environments, and are commended for your proactive attitude, then we'd love to welcome you to our ANZ Quality team

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.

Key Responsibilities

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.

Requirements

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 4+ years’ experience in a QA/RA role, ideally in medical devices.

Is a natural problem-solver and thrives in a process-driven environment.

Benefits

- Flexible work arrangements for some roles after probation

- Generous discounts with hundreds of retailers

- Access to online well-being center

- Employee Assistance Program and regular wellbeing webinars

- Generous discounts on GN Hearing, Jabra, and SteelSeries products

- Gift vouchers for birthdays, service anniversaries, and values-based awards

- Free annual flu vaccinations

- Weekly fresh fruit deliveries

- Convenient office location close to public transportation

If this sounds like the opportunity you've been waiting for, we'd love to hear from you! Please note that we can only consider applicants with full, unrestricted Australian work rights.

Agencies: Our preference is to fill this role directly. Should we require further assistance finding the right candidate, we will reach out to our preferred recruitment partners.


About GN Hearing Australia Pty Ltd

North Ryde, NSW, Australia

This company does not have any further information provided at this time. We encourage you to research the company by searching for them to learn more about the company or role in question before applying.

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