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 a motivated and focused Quality Assurance Manager to join our Brisbane based team. A permanent, full-time position reporting to the General Manager, the role will suit someone looking to take responsibility for the Quality aspects of a complex medical device. Primarily based in our Northgate office, this role can also include some remote and flexible work arrangements, by agreement.

Responsible for the Quality aspects of our business, this role will champion quality within our organisation and support the CEO and GM to continue to drive 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:

- Being the internal champion for implementing, obtaining and retaining certifications in accordance with ISO 13485:2016, 21 CFR Part 820, and other applicable regulatory jurisdictions.
- Maintaining effectiveness and continuously improving Magnetica’s Quality Management System (QMS) including conducting Management Review Meetings.
- Managing the responses to audits (internal and external)



including assigning and coordinating non-conformances as well as corrective and preventative actions and investigations.
- Maintaining the repository of controlled documents and managing their update and review processes.
- Being the Management appointed representative in terms of Magnetica’s QMS.
- Working with Magnetica’s technical domain experts, Regulatory Affairs Manager, General Manager, Production Manager, Supply Chain Manager and wider team, to ensure the timely delivery of market ready, QMS compliant product offerings throughout the overall product lifecycle.
- Other duties as agreed with the CEO or GM from time-to-time.

Required Experience & Capability

- Quality Assurance experience within the medical device/biotech industry.
- Demonstrated experience of successfully leading and influencing individuals and teams to embrace and support the delivery of QMS compliant products.
- 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.
- Experience in management of design controls, collation of clinical evidence and transfer to manufacturing.
- 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 robust 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, this will drive and champion quality within our organisation.

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📌 Quality Assurance Manager (Queensland)
🏢 Talentum Connect
📍 Queensland