Principal Quality Systems Specialist

2 weeks ago

Sydney, Australia Cochlear Ltd Full time

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

Due to growth, an exciting opportunity exist for an experienced Quality specialist to join our global HQ in Sydney.

As the Principal Quality Systems Specialist reporting to the Quality Manager, you will be partnering with stakeholders across the global Cochlear business to drive the implementation of Quality initiatives and provide technical expertise to ensure that our QMS processes are compliant with regulatory requirements and business procedures.

Your responsibilities include:

- Leading the implementation of Quality Management System processes.
- Managing all stages of QMS continuous improvement projects from design through to implementation.
- Setting direction for the timely resolution of complex quality issues and leading process improvements, facilitating problem solving and continuous improvement activities across all QMS processes.
- Influencing stakeholders across the business to implement and maintain Cochlear enterprise QMS and business strategy.
- With the Quality manager, coordinate preparation of input for management review and provide recommendations for escalation to executive management.
- Building the organisation’s problem-solving capability by leading the development of training material, coaching and mentoring cross function departments on these methodologies.

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:

- Tertiary qualifications (minimum Bachelor’s degree) in Engineering, Science or related discipline
- Previous experience designing and enacting of Quality Management Systems, preferably ISO 13485, 21 CFR and strong proven experience interpreting regulatory requirements
- Good understanding of spreadsheets, creation of charts, manipulation of data
- Analysing data and interpreting metrics
- Communicating effectively with cross functional departments
- Negotiating and working with a variety of stakeholders towards successful outcomes
- Previous practical experience in facilitating process improvements across global teams and end to end processes
- Strong interpersonal skills, and ability to collaborate with colleagues across the globe

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.

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.

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.

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