Senior Quality Assurance Specialist

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GN Group is seeking a Senior Quality Assurance Specialist to lead QA and regulatory for ANZ in Sydney. You’ll act as the local ISO13485 SME, drive compliance, run internal audits, coordinate Management Reviews, and lead CAPA boards, while overseeing product and spreadsheet validations and regulatory submissions with global QA/RA. Essential: at least 4 years’ ISO13485 experience in medical devices, strong knowledge of Australian regulations (TGA), hands on auditing, process validation and risk assessment, plus a science or related degree and excellent communication. Desirable: TGA Advertising Code experience, people management exposure, and additional validation or biocompatibility training. To apply, tailor your CV with concrete audit outcomes, CAPA improvements, and cross-functional impact.

At GN Hearing, we’re driven by a simple but powerful purpose: to make life sound better. As one of the world’s leading innovators in hearing solutions, we combine cutting-edge technology, quality, and care to transform lives every day.

We’re now looking for a Senior Quality Assurance Specialist to join our high-performing Operations team in Sydney. This role is pivotal in ensuring compliance with ISO13485, local regulations, and GN’s global quality management system across Australia and New Zealand.
 

What You’ll Do

As the Senior QA Specialist, you will:

• Lead and manage day-to-day Quality and Regulatory requirements for the ANZ business.

• Act as the local Subject Matter Expert for ISO13485 and quality processes, driving compliance across the organisation.

• Conduct internal audits, coordinate Management Reviews, and lead CAPA board meetings.

• Oversee custom product validation and spreadsheet validation activities.

• Partner with global QA/RA teams on process improvements and issue resolution.

• Manage ANZ vigilance reporting, complaints handling, and regulatory submissions.

• Train colleagues on quality and regulatory requirements to uplift knowledge across the business.

• Provide expert input into risk assessments, supplier qualification, and continuous improvement initiatives.

What You’ll Bring

We’re looking for a quality professional who is motivated, proactive, and passionate about improving systems and outcomes. You will have:

Essential

• Minimum 4 years’ experience with ISO13485 in a medical device production environment.

• Strong knowledge of Australian medical device regulations (TGA).

• Hands-on experience in auditing, process validation, and risk assessment.

• Excellent communication skills, with the ability to influence at all levels.

• A science, biochemistry, or related degree.

Desirable

• Experience with TGA Advertising Code compliance.

• People management exposure.

• Additional training in validation, biocompatibility, or risk assessment

• Product Quality Engineering experience

Why Join Us?

• Be part of a global organisation that genuinely improves lives.

• Work with a passionate and collaborative ANZ QA/RA team, connected with global colleagues.

• Enjoy a permanent, full-time role in our shiny new Sydney facility with a supportive and inclusive culture.

• Access opportunities for professional growth, learning, and development.

Please note: We’ve got this recruitment process covered. Should we require external support, we will reach out to our preferred recruitment partners directly.