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 Quality Engineer ensures regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, providing guidance and training to stakeholders to meet FDA 21 CFR Part 820 and (EN) ISO 13485 (and related standards). Key responsibilities include assisting in identifying, evaluating, containing, investigating, and applying corrections and corrective actions for Class 3 Active Implantable Medical Devices across Manufacturing and Logistics.
The Quality Engineer will also provide ongoing support to Manufacturing and Engineering teams when potential quality issues are identified and identify and implement improvements that will ensure Cochlear continues to effectively produce compliant products that satisfy customer, regulatory and business requirements. In addition to this, they will also be responsible for providing Quality System & Regulatory mentoring and direction to other departments.
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.
The Opportunity
Cochlear has an opportunity for a Quality Engineer based in our Sydney Offices (Macquarie Park and Lane Cove West). In this role, the successful Quality Engineer will ensure the quality and compliance of Cochlear products by supporting problem solving processes and acceptance, and reviewing, improving, and reporting the QMS process.
Responsibilities include:
- Support the Non-Conformance Report (NCR) process with regular problem-solving meetings to provide direction and support for the stakeholder.
- Support First Time Quality, Fast Response and Morning Market meetings and assist in Corrective and Preventive Activities (CAPA).
- Participate in QMS Continuous Improvement Activities (15%) through identifying, initiating, and implementing improvements to QMS processes.
- Review QMS documents for proposed changes and conduct regular internal audits and product reviews.
- Produce key performance metrics and data analysis on Non-Conformance Reports.
- Partner with Process Engineering and Validation teams to design Manufacturing Quality Plans that are practical, and risk based. Support MQP implementation and assess opportunity to tighten or reduce sampling.
- Ensure timely delivery of periodic reports and scheduled activities and effective process monitoring practices are followed, including escalation for negative or adverse trends.
- Translate Quality requirements and learner needs into an appropriate and effective training content so that all employees are well-equipped to understand each QMS process.
- Ensure appropriate level of training is delivered for process changes and improvements.
- Develop learning materials and provide training/coaching to others in these tools as required.
What makes this opportunity unique?
The role of Quality Engineer provides the unique opportunity to champion and drive initiatives toward the consistency, standardisation, and compliance of the Quality department’s strategic direction. This includes establishing operational networks within Cochlear and collaborating with other departments to improve QMS processes and witnessing the impact of the role in delivering the quality of Cochlear products to customers.
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:
Required Skills
- Awareness of regulations of QMS standards - ISO9001, ISO13485, FDA QSR.
- Knowledge of how to analyse processes, identify issues, including the application of problem-solving methodologies.
- Application of risk-based methodologies to identify solutions to issues recognised.
- Knowledge of Quality in manufacturing operations.
- Ability to work independently as well as in collaboration with other teams and departments.
Desired Skills
- Sound organisational and interpersonal skills: including the ability to competently liaise and provide feedback to internal and external customers regarding project issues.
- Direct experience with implementation of improved or new QMS processes.
- Quality engineering experience in a (Class 3) regulated environment an advantage.
- Direct quality experience in non-conformance, CAPA, SPC, Internal/Supplier Audit activities
- Proficient in writing procedural and technical documents.
- Passion for consistency, standards, accurate and complete documentation.
Education
- Engineering or Science degree or equivalent
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.
