Senior Quality Assurance Specialist

GN Hearing Australia; Ryde; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Digital reward platform with discounts

Wellbeing webinars

Volunteer leave

Discounts on GN products

Birthday gift

Free annual flu vaccinations

Onsite fruit and refreshments

Job summary

GN Hearing Australia in Sydney is seeking a Senior Quality Assurance Specialist to drive ISO13485 compliance, regulatory submissions, and quality processes across Australia and New Zealand. You will lead internal audits, CAPA boards, and liaison with global QA/RA teams.

Join a high-performing Operations team with opportunities to implement process improvements, risk management and supplier qualification while uplifting regulatory knowledge across the business.

Qualifications

• 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.
• Experience with TGA Advertising Code compliance.
• Additional training in validation, biocompatibility, or risk assessment
• Product Quality Engineering experience.

Responsibilities

• 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.

Skills

ISO13485 experience

Auditing

Regulatory knowledge

Risk assessment

Communication

Education

Science/biochemistry degree

Job description

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

• 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

• 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.
• Experience with TGA Advertising Code compliance.
• Additional training in validation, biocompatibility, or risk assessment
• Product Quality Engineering experience

What you’ll enjoy at GN

• One-on-one training in our systems, products and processes
• A digital reward & recognition platform with discounts at hundreds of retailers
• Employee Assistance Program and wellbeing webinars
• Service recognition and performance awards
• A gift for your birthday
• Free annual flu vaccinations
• Volunteer leave
• Generous discounts on GN products
• Fresh fruit, refreshments and a table tennis table onsite
• Opportunities for development and career growth

Why you’ll love it here

At GN, we put the customer at the heart of everything we do and we’re looking for someone who shares that same passion. If this sounds like the opportunity you’ve been waiting for we’d love to hear from you.

Applicants must have full unrestricted Australian work rights.

Agencies: we prefer to fill this role directly. Should we need additional support, we will be in touch with our preferred partners.

GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. For GN Group, this creates an opportunity to further expand our position in the large audio and video peripherals markets. Read more about the announcement here.