Senior Quality Systems Specialist

4 weeks ago

Sydney, New South Wales, Australia C01 Cochlear Limited (Australia) Full time

Cochlear, a global leader in implantable hearing solutions, is seeking a Senior Quality Systems Specialist to join our global HQ in Macquarie Park, Sydney on a 6 month Fixed Term Contract.

The successful candidate will be responsible for coordinating and evaluating QMS processes through supporting and coordinating initiatives that improve the compliance and execution of QMS standards across the business.

Key Responsibilities:

  • Provide quality systems SME support for Business departments and regional partners through maintaining strong stakeholder relationships, including different functions and countries, and ensure time efficient and quality QMS processes.
  • Provide guidance and interpretation of regulations and standards through implementing compliance monitoring and opportunity identification utilising audit programs.
  • Facilitate issue management (CAPA, NCR) activities and practises, including problem definition, root cause analysis, implementation, and effective verification actions to provide specialist support to the global business.
  • Facilitate Change Review Board meetings to ensure management oversight and achieve key decisions for ongoing QMS process changes.
  • Oversee QMS process change management and training processes including change definition, impact assessment, implementation, effectiveness and delivery of quality training programs and learning pathways.
  • Monitor and measure the health of QMS processes, using appropriate tools to track and report key performance indicators and metrics to identify areas of non-compliance and improvement opportunities.
  • Maintaining inspection ready procedures, data and records pertaining to the QMS and participating in internal and external audits and regulatory inspections.

About the Role:

This is an exciting opportunity to be involved in driving the organizational success of the global business by improving regulatory standards and quality assurance and collaborating with different functions of the business. This encompasses mentoring and training team development by implementing effective change and issue management processes.

Requirements:

  • Tertiary qualification in science or engineering or related discipline
  • 5+ year's medical device quality experience in a medical device or life sciences technology driven company
  • Previous experience with Quality Management systems in a highly regulated environment
  • Experience with implementation of processes, systems and reporting tools
  • Experience with continuous improvement methodology and process control techniques
  • Experience with issue management processes (CAPA, NCR) and root cause analysis tools and techniques
  • Demonstrated ability to produce high quality documentation

Cochlear is a place where our people truly enjoy coming to work. 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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