Working with clients in medical genomics laboratories, research institutions as well as community and healthcare providers to ensure regulatory compliance to ISO15189, ISO13485, ISO 9001, GLP, the NDIS Practice Standards and the Aged Care Standards. Working closely with senior management and with staff at levels to design, develop, implement and maintain quality systems that save organisations significant amounts of time and money as well as ensure patient safety and operational… Show more Working with clients in medical genomics laboratories, research institutions as well as community and healthcare providers to ensure regulatory compliance to ISO15189, ISO13485, ISO 9001, GLP, the NDIS Practice Standards and the Aged Care Standards. Working closely with senior management and with staff at levels to design, develop, implement and maintain quality systems that save organisations significant amounts of time and money as well as ensure patient safety and operational improvement. Services include:Gap analysis• Drawing on experience as an internal and external auditor across sectors• Comprehensive gap analyses to regulatory requirements including ISO 15189, ISO13485, ISO 9001, NPAAC guidelines, GLP, the NDIS Practice Standards and the Aged Care Standards• Clearly identifying compliance gaps• Providing clear, actionable project plans for improvementQuality Management Systems Development• Create and implement robust, compliant quality processes and systems inclusive of internal auditing, electronic QMS / DMS, risk management, non-conformance, deviation, improvement and CAPA management, training and competency management, documentation development and quality and objective setting.Maintenance and Bespoke Services• Tailored services to assist clients to maintain any or all of their quality management requirements• Tailored training programsExternal Audit• Delivering external audits to clients seeking accreditation under the NDIS Practice Standards Show less

Responsible for working closely with the management team to refine the Quality Management System and oversee all aspects of quality management. Achieved ISO 15189 / NPAAC accreditation.

Designing, refining and implementing Quality Management System to ISO 15189 and the NPAAC standards. Managing and supporting quality management operations including actively resolving quality issues, managing CAPA's, document control, risk management, training and competence.

Led the internal audit function for the whole of organisation including regulatory frameworks across corporate services as well across all clinical and practice streams. Service streams include Aged Care, Disability Supports, Families and Young People and Multicultural Support.

Providing effective leadership to and responsible for the overall operation and of the Quality Management System. Oversee applicable regulations are met such as ISO 15189 and NPAAC for new and existing products. Relate and function effectively with applicable accrediting and regulatory agencies and other stakeholders.Ensures quality system approach to developing, implementing and reviewing all operating systems. Leading internal audit programme, including reporting findings and… Show more Providing effective leadership to and responsible for the overall operation and of the Quality Management System. Oversee applicable regulations are met such as ISO 15189 and NPAAC for new and existing products. Relate and function effectively with applicable accrediting and regulatory agencies and other stakeholders.Ensures quality system approach to developing, implementing and reviewing all operating systems. Leading internal audit programme, including reporting findings and resolution.Managing and supporting quality management operations, including managing complaints, CAPA's, non-conformances, deviations and change controls, document control, risk management, selection and monitoring of suppliers, referral laboratories as well as training and competence.Developing and delivering professional development programmes in quality management principles and application for staff and international clients. Show less

Led a clinical practice improvement project to deliver enhanced outcomes, efficiency and access to services.

Health Professional in the care of COVID-19 patients in Intensive Care Units during peak of pandemic.

As Quality Manager and member of the Executive Management Board and Executive team I designed, developed, implemented and maintained the quality management system and associated accreditation to ISO 9001:2015 from inception to maturation.Designed quality management processes and systems to the NDIS Practice StandardsActed as Human Resource Manager from April 2018 – November 2018 completing generalist human resource activities including recruitment, contracts, system review… Show more As Quality Manager and member of the Executive Management Board and Executive team I designed, developed, implemented and maintained the quality management system and associated accreditation to ISO 9001:2015 from inception to maturation.Designed quality management processes and systems to the NDIS Practice StandardsActed as Human Resource Manager from April 2018 – November 2018 completing generalist human resource activities including recruitment, contracts, system review, audit, performance reviews/management and policy development.Managed large-scale health services development projects from inception until service delivery and review. Show less