Director of Global Quality Systems
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.
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, FDA QMSR, and other regulations; 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 to take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
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