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Quality Systems Lead

Apply now Job no: 608761
Work type: Permanent
Location: Sydney
Categories: Quality & Regulatory, Oceania, People Manager


About Us

Cochlear is the global market leader in implant hearing solutions and is a top 100 company on the ASX. 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. 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 people to Hear Now. And Always.

About the Role

We have a new permanent opportunity available at Cochlear for a suitably qualified Quality Systems Lead as part of our Quality Systems Assurance team.  The Quality Systems Lead plays an integral role in supporting business outcomes and priorities by implementing efficiencies, effectiveness and standardisation into the QMS and thus ultimately creating value for the organisation. This role will also be responsible for the management and development of an experienced team.

As a Quality Systems Lead you will have the opportunity to liaise with the Quality Systems Assurance Manager to determine and implement the processes needed for maintaining and improving an effective quality management system (QMS). It will require you to lead a team responsible for the document control, training, and continuous improvement processes, oversee QMS governance and recommending actions for improvement to the QMS.

In this role you will be responsible for:

  • Developing the processes required for sustainable continuous improvements of QMS processes by collaborating with the Quality Systems Assurance Manager;
  • Ensure continued operational suitability and effectiveness of the QMS and infrastructure;
  • Liaise with management and key stakeholders to ensure electronic documentation platforms support QMS and business requirements;
  • Build quality capability and effectiveness by developing training programs that are effective, efficient and commensurate to risk, and aligned with the OneQMS Global Strategy requirements;
  • Develop the function and capabilities of the Document Control Group to support the Global QMS requirements whilst driving continuous improvement.
  • Support, grow and develop an experienced Quality Systems Assurance Team.

Key Requirements:                                                    

  • Relevant tertiary qualifications in Engineering, Science or related discipline;
  • Proven experience in quality management or regulatory affairs;
  • Relevant experience with development and implementation of global processes, systems and reporting tools.
  • Relevant experience in quality management system development, implementation and planning;
  • Relevant experience in ISO 13485, and FDA Quality System requirements;
  • Prior experience as a people manager, and in project management and deliverables;
  • Demonstrates exceptional communication and stakeholder engagement skills;
  • Exhibits strong organizational skills


  • Relevant experience in a medical device company that designs, manufactures and distributes active implantable medical devices;
  • Demonstrates strong leadership capability through developing global teams and executing other business initiatives.

Development Value of this Role:

  • Opportunity to work across organisational boundaries;
  • Liaise with leadership team of unit;
  • Ability to contribute to building and delivering OneQMS Global Strategy.

If you feel that you encompass the necessary experience and skills for this role then take the first step towards a career with Cochlear, a career you can be proud of, and apply online today.

Advertised: AUS Eastern Standard Time
Applications close: AUS Eastern Standard Time

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