Medical Device Quality Assurance jobs in Melbourne VIC

Reference Number: 5927
Category: Medical
Department: Molecular Imaging & Therapy
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Full time permanent position
Based in Heidelberg, Victoria
$94,478-$106,907 + salary packaging + super

Austin Health is the major provider of tertiary health services, health professional education and research across three campuses in the north-east of Melbourne and statewide. We have a highly engaged, diverse and collaborative workforce that is unified by our goal to help people live healthy and fulfilled lives.

About Molecular Imaging and Therapy Department

The Department of Molecular Imaging and Therapy is one of the largest Radiopharmaceutical Departments in Australia, and has comprehensive scientific and clinical service activities, as well as an internationally renowned research program. The Department produces radiopharmaceuticals on site with in-house cyclotrons, extensive radiochemistry facilities and QC laboratory enabling a wide range of diagnostic and therapeutic examinations and research studies

The position of Quality Assurance Associate at Austin Health allows support of services directly impacting patients’ lives and health outcomes, while giving opportunities to develop a wide range of skills and experiences in a rapidly expanding field.

About the role:
The Quality Assurance Associate plays an important role in safeguarding the quality, safety, and regulatory compliance of radiopharmaceutical manufacture across the radiochemistry and radiopharmacy teams.

Reporting to the Head of Radiopharmaceutical Sciences, the position assists in ensuring that all radiopharmaceutical preparation, QC testing and documentation meet the required regulatory. They will support the running of the day-to-day quality management system operations including audits, non-conformance investigations, environmental monitoring, reviewing batch records, SOP management and reviewing training records.

The Quality Assurance Associate will also be involved in supporting development and clinical projects to improve components of the quality management system and assist in validation of new radiopharmaceuticals for clinical use. They will be trained and validated for routine radiopharmaceutical productions, and lab procedures, assisting in these when required.

Specific tasks of this role include:
Assist in running the departmental quality management systems (QMS), including SOPs, deviation logs, CAPA records, and document control.
Review and verify radiopharmaceutical batch documentation to ensure completeness, accuracy, and compliance.
Conduct and trend environmental and aseptic monitoring data for cleanrooms, hot cells, and preparation areas.
Assist in preparation, conducting and evaluation of routine and ad-hoc audits within the department.
Support scientific staff on incident and deviation management including non-conformances, out of specification and CAPA initiation.
Assist in co-ordination of equipment maintenance scheduling and records.
Review of raw material conformance and release for use in clinical setting.
Support training of staff in QMS and quality based procedures.
Become trained, validated and assist with routine radiopharmaceutical productions and lab-based activities when required.
Assist in the implementation and validation of novel radiopharmaceuticals for clinical use.
Participate in relevant meetings and preparation of accurate reports.
Perform lab-based tasks in a safe and accurate manner.
Be a team player and show consistent professionalism and integrity.
Attend further education courses or professional conferences as deemed necessary.

About you

To be successful in this role, you’ll have:
Bachelor’s degree in a relevant scientific field
>2 years experience working within a GMP environment
Substantial experience in the application of and leading projects within a QMS
Experience working in laboratory settings
Critical thinking and attention to detail
High levels of initiative and self-motivation
Well-developed communication and information technology skills
Ability to work as a team member and achieve projected goals and targets
Ability to work effectively as part of a wider team.

Desirable but not essential:
Whilst not mandatory, a relevant post-graduate degree would be highly regarded
Experience in Radiochemistry and/or Radiopharmacy
Experience in manufacturing Quality Control procedures and instrumentation such as HPLC, GC and TLC.

Our benefits

Working at Austin Health means enjoying a strong sense of purpose, engaging in meaningful work every day. Our people also receive a variety of rewarding benefits, including:

Greater take-home pay through generous salary packaging, for living expenses, meals, and holiday accommodation.
A suite of wellness initiatives designed to support you, including discounted fitness memberships and special offers on health insurance, and a comprehensive wellbeing program.
Onsite childcare at Austin Hospital, easy access via public transport and car parking options.
Mentoring and career development opportunities.
Purchased leave options.
Paid conference and exam leave.

Work with us!

We are committed to cultural safety and health equity for Aboriginal and/or Torres Strait Islander People. We celebrate, value, and include people of all backgrounds, genders, identities, cultures, bodies, and abilities. We welcome and support applications from talented people identifying as Aboriginal and/or Torres Strait Islander, people with disability, neurodiverse people, LGBTQIA+ and people of all ages and cultures.

If you feel this role is right for you, we encourage your early application. Even if you don’t meet every single requirement, we encourage you to apply. What matters most is your passion, your drive and your willingness to learn and contribute. Applications will be reviewed as they are received, and interviews may take place prior to the closing date. This means we reserve the right to close a job ad prior to the advertised closing date.

All appointments are made subject to a satisfactory National Police Check and if required, a Working With Children Check. Austin Health is a child safe organisation, committed to upholding the rights, safety, and wellbeing of children and young people in line with Child Safe Standards. If you require any reasonable adjustments to the recruitment process, you are welcome to reach out to the hiring manager: Dr Stuart McCluskey, Head of Radiopharmaceutical Sciences at Stuart.MCCLUSKEY@austin.org.au.

Interested in finding out more about this opportunity? Read the position description for further details.

Application closing date: Sunday 4 October 2026

Application instructions:
Please note you will be required to attach copies of the following to your online application:

Cover letter
Current Curriculum Vitae (CV)

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