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. GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them. The GN-owned brands that are responsible for bringing these technologies to life: Medical grade hearing technology: ReSound (https://www.resound.com/en) , Beltone (https://www.beltone.com/en) , Interton (https://www.interton.com/en) , Jabra (https://www.jabra.com/hearing) Professional collaboration: Jabra (https://www.jabra.com/) , BlueParrott (https://www.emea.blueparrott.com/) , FalCom (https://falcom.gn.com/) Gaming, calls and media: SteelSeries (https://steelseries.com/) , Jabra (https://www.jabra.com/) Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world. If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn (https://www.linkedin.com/company/gn-store-nord/) , Facebook (https://www.facebook.com/gnstorenord/) and Twitter (https://twitter.com/gnstorenord) . We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA individuals, and persons with disabilities are encouraged to apply. Come join our team!
