Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time. Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear. The Opportunity Cochlear has an opportunity for a full time Senior Quality Systems Engineer based in our Macquarie, Sydney office. In this role, the successful Senior Quality Systems Engineer will assist to ensure overall QMS compliance with applicable regulatory requirements and will interface with various departments across the organisation. Specifically, the Senior Quality Systems Specialist will maintain and support the execution of the Quality Management System (QMS) at CLTD and across the global business. Responsibilities include: Drive and facilitate collaborations across multiple functions and regions to help problem-solve and produce effective solutions Provides technical critical evaluation through all issue management process stages, including problem definition, root cause analysis, implementation, and effectiveness verification actions. Guide and mentor process change owners through all stages of the QMS change management process, including change definition, impact assessment, implementation and effectiveness. Monitor and measure the health of QMS processes, using appropriate tools to track and report key performance indicators and metrics to identify areas of non-compliance and improvement opportunities. Champion successful audit outcomes globally – tender, regulatory, unannounced, pre- and post-market inspections What makes this opportunity unique? The Senior Quality Systems Specialist role offers strong developmental value by building expertise in quality systems, regulatory compliance, and issue management within a highly regulated environment. It also strengthens leadership, collaboration, and training skills, preparing individuals for advancement into senior quality or compliance roles. About You To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience: Required Skills Critical/analytical thinker with demonstrated problem-solving skills and facilitation of problem-solving activities Strong communication skills with demonstrated ability to collaborate with and influence stakeholders to deliver optimal outcomes Ability to work effectively both independently and as a member of a cross-functional team Highly organized and experienced in project management and deliverables Flexible and adaptable with ability to manage multiple priorities to deadline Strong attention to detail Demonstrated ability to produce high quality documentation Desired Skills Experience in ISO 13485, and FDA Quality System Requirements Experience working in a medical device company that designs, manufactures and distributes active implantable medical devices. Work Experience 3 year’s medical device quality experience in a medical device or life sciences technology driven company Previous experience with Quality Management systems in a highly regulated environment Experience with implementation of processes, systems and reporting tools Experience with continuous improvement methodology and process control techniques Experience with issue management processes (CAPA, NCR) and root cause analysis tools and techniques Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities. If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below. CochlearCareers How we recognise your contribution We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you. For more information about Life at Cochlear, visit www.cochlearcareers.com At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.