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
An exciting opportunity exist for a Senior Quality Systems Specialist to join our global HQ in Macquarie Park, Sydney on a 15 month Fixed Term Contract. The successful Senior Quality Systems Specialist will be responsible for coordinating and evaluating QMS processes through supporting and coordinating initiatives that improve the compliance and execution of QMS standards across the business.
Responsibilities include:
- Provide quality systems SME support for Business departments and regional partners through maintaining strong stakeholder relationships, including different functions and countries, and ensure time efficient and quality QMS processes.
- Provide guidance and interpretation of regulations and standards through implementing compliance monitoring and opportunity identification utilising audit programs.
- Facilitate issue management (CAPA, NCR) activities and practises, including problem definition, root cause analysis, implementation, and effective verification actions to provide specialist support to the global business.
- Facilitate Change Review Board meetings to ensure management oversight and achieve key decisions for ongoing QMS process changes.
- Oversee QMS process change management and training processes including change definition, impact assessment, implementation, effectiveness and delivery of quality training programs and learning pathways.
- 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.
- Maintaining inspection ready procedures, data and records pertaining to the QMS and participating in internal and external audits and regulatory inspections.
What makes this opportunity unique?
The Senior Quality Systems Specialists leverages specialized expertise and leadership in executing pivotal Quality Management System (QMS) processes. This role provides the opportunity to be involved in driving the organizational success of the global business by improving regulatory standards and quality assurance and collaborating with different functions of the business. This encompasses mentoring and training team development by implementing effective change and issue management processes.
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
- Tertiary qualification in science or engineering or related discipline
- 5+ 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
- 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.
What We Do
Hear now. And always
As the global leader in implantable hearing solutions, at Cochlear (ASX: COH) we are committed to our mission to help people hear and be heard. Our story started more than four decades ago when Professor Graeme Clark pioneered the world's first multi-channel cochlear implant and created an entirely new treatment for hearing loss.
Since our formation in 1981, we continue Professor Clark’s work to help people with moderate to profound hearing loss experience a life full of hearing.
We have provided more than 650,000 implantable devices. Each recipient helps form a global community of millions, through families, friends, colleagues, teachers and more. And they’re not just connected to their own community — each shares a link with each other and to Professor Clark’s childhood desire to help people hear.
We aim to give people the best lifelong hearing experience and access to innovative future technologies. We understand the privilege of connecting people to a life lived with hearing. And we listen, respond and move with the times – to continue to bring hearing within reach of all those who need it.
That's how we live our mission every day. Our global workforce of more than 4,000 people shares a collective determination to give more people the opportunity to enjoy a life of hearing.
Cochlear’s global headquarters are on the campus of Macquarie University in Sydney, Australia with regional headquarters in Asia Pacific, Europe and the Americas. Through our offices in over 180 countries we help people of all ages to hear.
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