Senior Quality Systems Specialist
vor 4 Wochen
Cochlear is the global market leader in implant hearing solutions. 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. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It's an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions.
The Opportunity
An exciting opportunity exists for a Senior Quality Systems Specialist to join our global HQ in Macquarie Park, Sydney on a 6 month Fixed Term Contract. The successful Senior Quality Systems Specialist 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.
Responsibilities include:
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 practices, 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.
What makes this opportunity unique?
The Senior Quality Systems Specialist leverages specialized expertise and leadership in executing pivotal Quality Management System (QMS) processes. This role provides the 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.
About You
As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
Essential
Tertiary qualification in science or engineering or related discipline
5+ years 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
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
How we recognise your contribution
We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel valued and supported.
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