Executive Level 1 - Canberra, Australia - National Health Funding Body
Description
Job Reference Number 23-MDPQDIV-16331
Classification Executive Level 1
Job Title Laboratory Manager
Division Medical Devices and Product Quality Division
Branch Laboratories Branch
Section Laboratories Business Operations Section
Location Fairbairn, ACT
Status Ongoing
Employment type Full-time
Salary Range $108,680 - $123,951
Mandatory Qualifications A degree or diploma in a relevant science or engineering field
from an Australian tertiary institution or other comparable
qualification or relevant experience.***
Contact Officer Name:Leisa Whitby
Phone:
Eligibility
- To be eligible for employment with the Department of Health and Aged Care
- An applicant's suitability for employment with Health will also be assessed through a
variety of pre-employment check processes, such as:
- Satisfactory completion of an Australian Federal Police criminal history check,
- Completion of a medical declaration and preemployment medical (where
- Providing evidence of qualifications.
Division Responsibilities
The Medical Devices and Product Quality Division (MDPQD) is part of the Health Products
Regulation Group. The division ensures Australian and international therapeutic goods
manufacturers and products meet the highest standards for quality, safety and
performance. MDPQD regulates the quality of therapeutic products for the Australian
community by:
assessing medical devices, including in vitro diagnostic tests; testing and
monitoring medical devices and medicines to help ensure they continue to meet
appropriate levels of quality, safety and performance; and auditing and certifying
manufacturers against manufacturing standards so the products they produce meet
appropriate quality, safety and performance standards.
Branch Responsibilities
The Laboratories Branch is responsible for post market monitoring and compliance testing,
investigations, and reviews, as well as market authorisation assessments for therapeutic
goods. The branch conducts laboratory testing in accordance with the laboratories testing
program; lot release; provides scientific expertise to assess technical data for marketing
authorisations; provides scientific and expert advice to internal stakeholders, committees,
government etc.; and participates in the development of standards and international
collaborative activities
Section Responsibilities
The Laboratories Business Operations Section provides operational support to the
Laboratories Branch by maintaining the Quality Management System, information
management, coordination of laboratory maintenance, management of the laboratory
testing program, and stakeholder engagement (including internal to the organisation,
nationally and internationally).The section also provides centralised coordination and
leadership for Laboratories Branch wide initiatives, including special projects and ongoing
business improvements, and is responsible for the management of the two WHO designated
Collaborating Centres***
Key Responsibilities
- Provide technical leadership, direction and coordination to scientific sections across
accreditation
- As the decision maker and financial delegate, manage the procurement of
programs, including coordinating and managing staff responsible for undertaking
these duties
- Oversee quality system activities, including scheduling testing of equipment and
administration, reviewing and updating technical documentation, and maintaining
training records, ensuring compliance with ISO17025 accreditation requirements
- Direct and coordinate technical activities of the laboratory to ensure services are
- Review and approve procedures for specific items of equipment, ensure standard
or building services
- Contribute to internal audits and implement / address corrective and preventative
works***- Manage complex and critical capital equipment procurements
- Manage and lead the Branch On Call Officers group responsible for ensuring
and ISO)
- Maintain relevant permits and licences
- Perfo
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