Quality Manager Biomedical Materials Translational
2 weeks ago
Acknowledgement of Country:
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia.
Child safety:
CSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs.
The opportunity:
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Bring your quality management experience to work:
Work within a supportive, rewarding, and collaborative team environment:
Join CSIRO
Australia's National Science AgencyMany of CSIRO's innovations were once considered impossible. Fast WiFi, Aerogard insect repellent and the plastic Australian banknote, to name a few. Until someone, just like you, joined us and took on the challenge. We're recruiting inventors, innovators and change makers. Join Team CSIRO and help make the impossible possible.
CSIRO's Biomedical Materials Translational Facility (BMTF) helps medtech companies turn new discoveries into market ready products. It has the capability and equipment needed to develop a product though prototyping, scale-up, pre-clinical testing and industry evaluation.
BMTF bridges a critical capability gap in the Australian Medtech value chain where many small and medium enterprises struggle to transition from R&D to a sustainable product.
To enable this capability the BMTF has a Quality Management System (QMS) certified to ISO 9001.In this Quality Manager role you will provide leadership in all aspects of quality management and assurance to support research and development activities including the development and implementation and/or administration of policies, systems, and procedures that assist the organisation to achieve its objectives and meet government and regulatory requirements.
Your duties will include:
- Facilitate ongoing implementation, development, updating, and monitoring of the BMTF's electronic quality management systems.
- Lead all accreditation processes, including facilitating both internal and external audits of laboratory areas with hazardous materials and equipment.
- Lead the review, approval, and distribution of technical documents, such as Work Instructions and Study Reports.
- Provide effective leadership in quality and risk management to assist facility users and Study Directors to continuously review their practices.
- Assist laboratory personnel with following quality management processes, including induction of new personnel and conducting training sessions on quality management topics.
- Maintain training records in accordance with the QMS and manage archiving and electronic backup of documents and records in accordance with the QMS.
- Manage deviation reports, nonconformances, corrective actions / preventive actions (CAPAs) and improvement opportunities.
- Maintain electronic records in the QMS software and restrict access to commercially sensitive information of CSIRO and/or research or commercial partners.
Location:
Clayton, Melbourne, VIC
Salary:
AU$110k - AU$119k plus up to 15.4% superannuation
Tenure:
Indefinite / Full-time
Reference:96738
To be considered you will need:
Essential
- Relevant bachelor's or higher degree or equivalent relevant work experience in a relevant discipline area, such as chemistry, biology, materials science, biomedical science or related disciplines.
- Experience of quality management within a research and/or development environment and the desire to learn new skills.
- High level written and oral communication skills with the ability to train colleagues, assist others with document writing.
- Firsthand experience in preparing for and providing representation in external audits by regulatory bodies.
- High level of attention to detail coupled with the ability to maintain accurate records.
- The ability to work collaboratively and productively with others as part of a multidisciplinary research team.
Desirable
- Relevant work experience in quality management under ISO 9001 or a related quality system.
- Experience with electronic document and compliance management systems (e.g. Q‐Pulse).
- Experience developing, implementing, and maintaining quality management systems.
- Experience with managing others in a quality role.
Eligibility:
Flexible working arrangements:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.
Diversity and inclusion:
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.
About CSIRO:
At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science an
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