Senior Quality Systems Specialist

6 hours ago

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

Cochlear, the global leader in implantable hearing solutions, is seeking a highly skilled Senior Quality Systems Specialist to join our global HQ in Macquarie Park, Sydney on a 15-month Fixed Term Contract.

Key Responsibilities
  • Provide quality systems SME support to Business departments and regional partners, maintaining strong stakeholder relationships and ensuring efficient QMS processes.
  • Guide and interpret regulations and standards through compliance monitoring and opportunity identification using audit programs.
  • Facilitate issue management activities, including problem definition, root cause analysis, implementation, and verification actions.
  • Oversee QMS process change management and training processes, including change definition, impact assessment, implementation, and delivery of quality training programs.
  • Monitor and measure QMS process health, using tools to track and report key performance indicators and metrics.
  • Maintain inspection-ready procedures, data, and records, participating in internal and external audits and regulatory inspections.
Requirements
  • Tertiary qualification in science or engineering or related discipline.
  • 5+ years of medical device quality experience in a highly regulated environment.
  • Previous experience with Quality Management systems and implementation of processes, systems, and reporting tools.
  • Experience with continuous improvement methodology and process control techniques.
  • Experience with issue management processes and root cause analysis tools and techniques.
  • Demonstrated ability to produce high-quality documentation.
About Cochlear

Cochlear is dedicated to helping people with hearing loss experience a life full of hearing. As the global leader in implantable hearing solutions, we collaborate with the industry's best clinical, research, and support networks. Join us in our mission to help more people hear and be heard.

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