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 Regional Senior Quality Specialist based in our Sydney, Macquarie office. In this role, the successful Regional Senior Quality Specialist will develop, maintain and ensure compliance with key processes and metrics that impact quality throughout the region.
Responsibilities include:
- Performing complex problem solving activities and monitoring effectiveness of various business processes.
- Participate in quality related activities that add strategic value to the business.
- Maintain documentation and records management systems, including change control, training, internal audit and management review.
- Maintain and manage quality agreements with third party distributors across the APAC region.
- Run internal audits and support external audits.
- CAPA, NCR and QMS management.
- Conducting solution focused root cause analysis that enable continuous improvements to the Quality System processes.
What makes this opportunity unique?
Develop and implement global quality management system integrated across manufacturers and regions, working with key stakeholders within Cochlear to drive greater awareness for Quality across Cochlear’s APAC operations.
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:
Essential:
- Track record of Success as a Quality Specialist in the Medical Device, Medical Technology or Pharmaceutical industries
- Highly organized and experienced in project management and deliverables.
- Experience with enacting or implementation of processes, systems and reporting tools.
- Experience with continuous improvement methodology and process control techniques.
- Experience in ISO 13485.
- Experience with operational quality in a sales and distribution environment.
- Able to quickly establish detailed product knowledge across the portfolio.
- Excellent communication skills at all levels of the organisation.
Ideal:
- Experience with developing and delivering presentations and training activities
- Experience with Medical Device regulatory requirements in China, Japan or India
- Proficiency in Mandarin (preferred)
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.
