Cochlear is the global market leader in implant hearing solutions. Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.
The Opportunity
Cochlear has an exciting opportunity for a Principle Quality Engineer. In this role, you will set direction and provide technical expertise to ensure Cochlear’s QMS processes and products comply with our procedures and global regulatory requirements. You will ensure the acceptance and release of Cochlear products are performed according to defined requirements and maintain an appropriate balance of quality, compliance, and business risk.

Key Responsibilities

• Provide guidance and support as a technical Quality SME, including to Manufacturing, Engineering, and Quality Engineers, through new product transfers, product change management, and identification of potential product quality issues.
• Facilitate complex product quality issues and lead problem-solving and continuous improvement activities.
• Demonstrate analytical thinking to provide insights through data review, enabling early detection of emerging issues.
• Report KPIs and process performance metrics to the business.
• Maintain a continuous learning mindset to stay updated with evolving technologies and industry practices.
• Coach and mentor Quality team members, supporting continuous growth of the team’s capabilities.

Required Skills

• Bachelor’s degree in a relevant scientific/engineering discipline.
• Understanding of regulatory requirements, e.g., ISO 13485/FDA regulations/MDSAP.
• Knowledge and experience in analyzing process data and identifying issues.
• Application of risk-based decision-making methodologies to identify timely solutions to issues.
• Excellent knowledge of design transfer and risk management processes.
• Excellent presentation skills with the ability to translate data and metrics to target audiences.
• Demonstrated experience in application and facilitation of problem-solving methodologies.
• Proficiency in data analysis with the ability to interpret, trend, and report on statistical control charts and process metrics.
• Minimum 7 years’ experience working in Quality Operations/Engineering within manufacturing operations in the Medical Device Industry.

Desired Skills

• Direct experience with the implementation of improved or new QMS processes.
• Quality engineering experience in a (Class 3) regulated environment is an advantage.
• Knowledge and understanding of the application of appropriate statistical methods, including CPK/PPK.
• Highly developed audit capability/experience (Internal and External Audits, i.e., MDSAP).
• Practical experience in facilitating process improvements across global teams and end-to-end processes.
• Good collaboration skills, experience in implementing global processes, and building intercompany relationships.

Developmental Value of this Role
This role offers the opportunity to work across the product and supply chain system, gaining exposure to high-impact issues and building relationships across the organization. You will have global exposure, working with multi-region Global Supply Chain and R&D teams, and contribute to significant improvements and innovations within the company.
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 life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.
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
We want Cochlear to be a place where our people truly enjoy coming to work. 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
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. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We’re open to a conversation about what flexibility means for you.

• Provide guidance and support as a technical Quality SME, including to Manufacturing, Engineering, and Quality Engineers, through new product transfers, product change management, and identification of potential product quality issues.
• Facilitate complex product quality issues and lead problem-solving and continuous improvement activities.
• Demonstrate analytical thinking to provide insights through data review, enabling early detection of emerging issues.
• Report KPIs and process performance metrics to the business.
• Maintain a continuous learning mindset to stay updated with evolving technologies and industry practices.
• Coach and mentor Quality team members, supporting continuous growth of the team’s capabilities