Magneticais a medical device engineering and technology company specialising in the development and supply of Magnetic Resonance Imaging (MRI) systems, sub-systems and technologies. Headquartered in Brisbane, Australia, we have offices in Abingdon, near Oxford, UK (Scientific Magnetics Ltd) and Houston, USA (Tecmag, Inc.).

With proven capabilities in R&D;, product commercialisation, manufacturing and supply, the company is at a stage of growth and opportunity to provide a unique integrated product offering in the MedTech sector. We are looking for a motivated and detail orientated person to join our team on a permanent basis, based in the Brisbane (Australia) office.

We are recruiting for an experienced Quality Assurance Associate to join our Brisbane based team. A permanent, full-time position reporting to the QA Manager, the role will suit someone looking to support the Quality aspects of a complex medical device. Primarily based in our Northgate office, this role can also include some remote and adaptable work arrangements, by agreement.

Responsible for the documentation and continual improvement aspects of our business, this role will contribute to driving a culture of quality throughout the business. As a rapidly growing company, this role provides the opportunity to directly contribute to our growth and success as we commercialise and deliver market-disrupting and regulatory compliant medical-device products.

Key elements of the role include:

- Contributing to the implementation and maintenance of certifications in accordance with ISO 13485:2016, 21 CFR Part 820, and other applicable regulatory jurisdictions.




- Continuously improving the Quality Management System (QMS) through Change Management.
- Evaluating non-conformances and planned deviations for compliance with requirements.
- Support the CAPA process and support stakeholders with CAPA investigation, RCA etc.
- Participating in the auditing processes (Internal and external).
- Maintaining the Controlled Documents.
- Support Records Management.
- Other duties as agreed with the QA Manager.

Required Experience & Capability

- Quality Assurance experience within the medical device/biotech industry.
- Relevant qualification(s) in field(s) of Quality, Engineering and/or Biotech/Medtech.
- Experience of working within an ISO 13485 and/or 21 CFR Part 820 accredited organisation though certification and recertification cycles.
- Relevant auditing experience, ideally including a qualification (ISO 13485) or having received external training.
- Experienced in MS programs and SharePoint.
- Demonstrated knowledge in EU MDR/US FDA/AU TGA/ NZ Medsafe regulations and guidelines.
- Experience in 510(k) submission preparation for US TGA review.
- Proven problem-solving ability.
- Approachable personality with strong communication (written and verbal) skills.
- Accuracy, attention to detail and task completion.
- Self-driven, organised and proactive.
- Ability to collaborate and support technical and non-technical staff to resolve ambiguity.

This is a unique role to support all Quality aspects of our business, responsible for the documentation and continual improvement aspects and contributing to driving a culture of quality.

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📌 Quality Assurance Associate (Brisbane)
🏢 Talentum Connect
📍 Brisbane