About this role
Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time. 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