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 solid 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.

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 setting.
Demonstratable experience working with Quality Management Systems in regulated industries.
Knowledge of ISO 13485 and medical device quality requirements.
Robust 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.

📌 Senior Quality Systems Specialist Sydney
🏢 Cochlear
📍 Sydney