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Senior Quality Manager - Digital Health
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation
The?unparalleled demands of COVID-19 have been a catalyst for increased focus on digitisation and innovation?in health. CSIRO’s national digital health research program, The?Australian e-Health Research Centre?(AEHRC)?is leading a?national?agenda focused on innovation to?foster continued transformation and sustainable healthcare delivery practices.? We’re championing the digital delivery of healthcare enabled by world-leading digital research and innovation,?industry?partnerships, community?connections,?and national trust.
With?over?100 scientists and engineers across Brisbane, Sydney, Melbourne, Canberra and Perth, the AEHRC is Australia’s largest digital health research program, and we’re hiring?a number of?talented researchers, engineers, leaders and project staff to contribute to our significant research objectives.??
As the Senior Quality Manager you will implement and maintain a Quality Management System (QMS) including compliance with the applicable regulations and guidelines, ISO 13485, 21 CFR 820, ISO 62304, ISO 14971. This is a hands-on quality role that will guide and collaborate with staff across a range of areas in the implementation and adoption of various ISO standards.
The Quality Manager is designated as the Management Representative for the QMS and has the responsibility and authority that includes ensuring that processes needed for the QMS are established, documented, implemented, and maintained; reporting to management on the performance of the QMS and any need for improvement; and ensuring the promotion of awareness of regulatory and customer requirements throughout the AEHRC and more broadly the Health & Biosecurity Business Unit and CSIRO.
The Quality Manager is also responsible for conducting management review meetings, regulatory reporting, post-market surveillance, coordinating production recalls and corrections, and reporting regularly to the Business Unit on all aspects of the QMS. The Quality Manager will play a key role in developing a validation framework for undertaking validation activities across the AEHRC and be responsible for assisting specific projects and advising on all QMS related requirements.
Location: Brisbane, Melbourne or Sydney based
Salary: AU$141k – AU$157k plus up to 15.4% superannuation
Tenure: Specified term of 3 years
Reference: 85355
For full details about this role please view the Position Description
Applications for this position are open to Australian Citizens, New Zealand Citizens and Australian Permanent Residents, and people already in Australia with full work rights for the term of the contract.
The successful applicant will be required to obtain and provide a National Police Check or equivalent.
We work flexibly at CSIRO, offering a range of options for how, when and where you work. Talk to us about how this role could be flexible for you. Balance
We are working hard to recruit diverse people and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish. Diversity and Inclusion Strategy
At CSIRO, Australia’s national science agency, we solve the greatest challenges through innovative science and technology.
Join us and start creating tomorrow today!
Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.
14 August 2022, 11:00pm AEST