Quality Manager Biomedical Materials Translational Facility
vor 4 Wochen
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Quality Manager Biomedical Materials Translational FacilityCSIRO 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
Child safetyCSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs. View ourChild Safe Policy .
The opportunity- Bring your quality management experience to work
- Work within a supportive, rewarding, and collaborative team environment
- Join CSIRO - Australia's National Science Agency
Many 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 thisQuality 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, non-conformances, 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
Reference: 96738
To be considered you will need:- 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.
- First-hand 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 multi-disciplinary research team.
- Relevant work experience in quality management under ISO 9001or 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.
Applications for this position are open to Australian/New Zealand Citizens and Australian Permanent Residents only. Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements.
Flexible working arrangementsWe work flexibly at CSIRO, offering a range of options for how, when and where you work.
Diversity and inclusionWe 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 CSIROAt CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact.
CSIRO is committed to values-based leadership to inspire performance and unlock the potential of our people.
Join us and start creating tomorrow today
How to applyPlease apply on-line and provide a cover letter and CV that best demonstrateyour motivation and ability to meet the requirements of this role.
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