Senior Quality Systems Specialist
4 weeks ago
Cochlear is a global leader in implantable hearing solutions, dedicated to helping people with severe hearing loss experience a life full of sound. As a Senior Quality Systems Specialist, you will play a pivotal role in driving the organizational success of our global business by improving regulatory standards and quality assurance.
The Opportunity
We are seeking a highly skilled and experienced 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, supporting and coordinating initiatives that improve 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.
- 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.
- 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.
- Maintain inspection ready procedures, data, and records pertaining to the QMS and participate in internal and external audits and regulatory inspections.
About You
To be successful in this role, you will have a tertiary qualification in science or engineering, 5+ years of medical device quality experience in a highly regulated environment, and experience with Quality Management systems, implementation of processes, systems, and reporting tools, continuous improvement methodology, and process control techniques.
What We Offer
Cochlear is committed to creating an environment where our people can thrive, with flexible working arrangements, opportunities for continuous learning and professional development, and a culture that celebrates and leverages diversity and inclusion.
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