Senior Quality Assurance Specialist

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

Were 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 GNs global quality management system across Australia and New Zealand.

What Youll 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 Youll Bring

Were 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: Weve got this recruitment process covered. Should we require external support we will reach out to our preferred recruitment partners directly.