▷ [3 Days Left] Senior Quality Assurance Specialist

16 hours ago

Council of the City of Sydney, Australia GN Group Full time

Senior Quality Assurance Specialist page is loaded## Senior Quality Assurance Specialistlocations: Sydneytime type: Full timeposted on: Posted Todaytime left to apply: End Date: November 10, 2025 (30 days left to apply)job requisition id: R26809At 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* 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.*[](blob:https://gn.wd3.myworkdayjobs.com/6d9f06c1-6638-4c47-a815-32d9dbfe5f6e)0:00 / 6:29
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