Senior Quality Manager - Digital Health - [Archived Advertisement]
Senior Quality Manager - Digital Health
Acknowledgement of Country
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- Implement and maintain a QMS including compliance with regulations and ISO certifications
- Contribute to AEHRC’s research program and make improvements to healthcare in Australia
- Join CSIRO’s AEHRC! A truly collaborative, flexible and inclusive workplace
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.
Your duties will include:
- Provide strategic oversight and direction for the QMS and regulatory compliance.
- Implement and maintain the QMS and ensure compliance with all applicable regulatory requirements.
- Provide input and direction in the product development and production processes, including project planning, specification development, risk analyses, verification and validation activities, design reviews, design transfer activities, etc. for all projects.
- Facilitate training and promote general awareness of the QMS and regulatory requirements.
- Oversee the documentation control system and ensure compliance to ISO13485 and 21 CFR 820.
- Oversee the corrective and preventative actions (CAPA), engineering change control, complaint handling, post-market surveillance (PMS) and engineering change order programs.
- Where applicable, communicate with regulatory authorities, e.g., FDA, TGA, EU Competent Authorities, etc. Liaise with external regulatory organisations for ongoing maintenance of the QMS, product approvals and the preparation of new product regulatory submissions.
- Conduct internal and supplier QMS audits as per schedule or arrange for other qualified auditors to perform audits as required.
- As part of the AEHRC Leadership Team contribute to the strategic planning and assist in the preparation of the AEHRC QMS Annual Report for Senior Management which assesses the effectiveness of all elements of the quality system in meeting the objectives of the Centre and the requirements of ISO Standards.
Location: Brisbane, Melbourne or Sydney based
Salary: AU$141k – AU$157k plus up to 15.4% superannuation
Tenure: Specified term of 3 years
To be considered you will need:
- Demonstrated experience with a minimum of 5 years in in a regulatory and quality role, in the medical device industry.
- Experience and knowledge in medical device regulations and quality management standards such as ISO 13485, 21 CFR 820, ISO 62304, ISO 14971 and their application.
- Demonstrated experience in taking multiple products to market including regulatory approval.
- Proven experience in managing quality teams and influencing business decisions to align to quality standards.
- Demonstrable experience as a specialist advisor and contributor to teams and networks of scientific and industry colleagues, with a proven ability to lead and foster a culture of knowledge transfer, open communication, coaching and collaboration.
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.
Flexible Working Arrangements
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
Diversity and Inclusion
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!
How to Apply
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
- Closing Date:
- 14 Aug 2022
- AU$141k – AU$157k plus up to 15.4% superannuation
- Work Type: