Senior Quality Systems Specialist
5 days ago
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.
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 to Business departments and regional partners, maintaining strong stakeholder relationships and ensuring efficient QMS processes.
- Offer guidance and interpretation of regulations and standards through implementing compliance monitoring and opportunity identification using audit programs.
- Facilitate issue management (CAPA, NCR) activities and practices, including problem definition, root cause analysis, implementation, and 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, 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.
- Maintain inspection-ready procedures, data, and records pertaining to the QMS and participate in internal and external audits and regulatory inspections.
Cochlear values and welcomes the unique contributions, perspectives, experiences, and backgrounds of our employees, aiming to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realize their full potential.
We offer flexible working arrangements and understand that flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.
About YouTo be successful in this role, you'll need to demonstrate the following skills and experience:
- Tertiary qualification in science or engineering or a related discipline.
- 5+ years of 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'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.
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