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Form of workCochlear 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
We have an opportunity for Senior Quality Systems Specialist to join our global HQ in Sydney. In this role, you will be reporting to the Quality Manager, and work on critical QMS processes and act as an active advocate for the Quality function while partnering with the business.
Your responsibilities include:
- Ensuring Cochlear's QMS processes are in compliance with global regulatory requirements procedures.
- Facilitating quality issues, process improvements, problem solving and continuous improvement activities.
- Monitoring process performance of the QMS.
- Participating in all stages of QMS continuous improvement projects.
- Influence and guide stakeholders to successfully enact QMS process in a timely and compliant manner and to high-quality standards.
- Supporting CAPA and NCR owners to make decisions that are made based on use of data and problem-solving techniques.
- Providing technical evaluation through all issue management process stages, including problem definition, root cause analysis, implementation, and effectiveness verification actions.
- Facilitating Issue Management and Process Change Review Board meetings.
- Preparing Quality monthly metrics reporting, product insights reporting, and management review meetings
About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
- Tertiary qualifications in Engineering, Science or related discipline
- Previous experience and knowledge of Quality Management Systems, preferably ISO 13485, 21 CFR
- Experience with implementation of processes, systems and reporting tools
- Critical/analytical thinker and demonstrated experience with issue management processes (CAPA, NCR) and root cause analysis tools and techniques
- 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
- Flexible and adaptable with ability to manage multiple priorities to deadline
- Strong attention to detail
- Demonstrated ability to produce high quality documentation.
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.
