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.
We’re looking for a strategic leader to drive our Quality Management System (QMS) across global manufacturing sites, ensuring compliance, innovation, and a culture of quality that delivers life-changing hearing solutions to customers worldwide.
As Director, Global Quality Systems, you’ll lead the definition, maintenance, and continuous improvement of QMS processes across Cochlear’s manufacturing sites. Reporting to the VP Global Quality Systems & Customer Quality Assurance, you’ll ensure compliance with global regulatory standards and deliver quality strategies that meet customer expectations.
You’ll oversee key processes including documentation and change management, standards management, internal and external audits, QMS training, issue management, CAPA, and field actions. Working closely with regional quality leaders and senior business stakeholders, you’ll build a strong quality culture through training and awareness programs. Quality Systems Managers across CLTD, CBAS, and CVS will report to you, ensuring QMS certification and operational excellence.
About the role:
Lead Global QMS Strategy & Compliance
Define, maintain, and continuously improve QMS processes including documentation, change management, audits, training, issue management, CAPA, and field actions.
Drive CAPA Program Effectiveness
Oversee investigations, ensure timely resolution, and embed learnings into system improvements.
Champion Quality Culture
Lead training and awareness programs, mentor teams, and build capability across regions.
Ensure Audit & Regulatory Readiness
Maintain compliance with ISO 13485, EU MDR, MDSAP, and FDA QMSR and other regulations as required; coordinate inspections and audits globally.
Enable Continuous Improvement
Monitor quality objectives, prepare management reviews, and support enterprise-wide quality initiatives.
Collaborate Globally
Work with senior leaders to align manufacturing processes with enterprise quality strategies.
What You Bring
Expertise in QMS for medical devices and global regulatory standards.
Experience leading global quality teams, managing people managers, and driving cross-functional collaboration.
Skills in project management, global process implementation, and data-driven decision-making.
Leadership that inspires teams, fosters innovation, and builds a strong quality culture.
Preferred: Background in medical device manufacturing and global product launches.
Why Join Us?
Make a global impact by shaping quality strategies that enable life-changing technology.
Lead innovation and continuous improvement in a dynamic, purpose-driven environment.
Collaborate with world-class teams and senior leaders across the globe.
Thrive in a culture that values curiosity, learning, and excellence.
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
Top 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.
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