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 world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.
The Opportunity
Cochlear now has a 12-month contract opportunity for a Senior Quality Systems Specialist to support and maintain the execution of Cochlear’s Quality Management System (QMS) across the global business. In this role, you will provide specialist quality systems support and consultation, with a strong focus on issue management, process change management and documentation management. Working closely with business functions and regional partners, you will help ensure QMS processes are delivered effectively, consistently and in compliance with regulatory requirements.
Based in our global headquarters, this fixed-term contract has the possibility of being extended or becoming permanent for the right candidate.
The Responsibilities
- Provide quality systems expertise and support to business functions and regional partners.
- Lead issue management activities, including CAPA and NCR processes.
- Facilitate issue review boards and support quality-related decision making.
- Guide stakeholders through QMS change management activities.
- Monitor QMS performance and drive continuous improvement initiatives.
- Support internal, external and regulatory audits and maintain audit readiness.
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:
- 5+ years' experience in a medical device or life sciences environment.
- Demonstratable experience working with Quality Management Systems in regulated industries.
- Knowledge of ISO 13485 and medical device quality requirements.
- Strong communication, stakeholder engagement and influencing skills.
What makes this role unique
This role provides broad exposure to Cochlear’s global Quality Management System and the processes that support product quality and regulatory compliance. You will partner with stakeholders across functions and regions, contribute to continuous improvement initiatives, and build expertise in quality systems, issue management and compliance within a global medical device organisation.
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
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. 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
Skills Required
- 5+ years of experience in a medical device or life sciences environment
- Experience working with Quality Management Systems in regulated industries
- Knowledge of ISO 13485 and medical device quality requirements
- Strong communication, stakeholder engagement, and influencing skills
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. Social Media Terms of Use http://bit.ly/2qRMEvY
