Careers
We are recruiting to fill a number of roles as we gear up for growth. Interested in the opportunity to live and work in Brisbane (Australia), near Oxford (UK) or Houston (US)?
Email us your CV and an applicable covering letter explaining your suitability today!
Quality Assurance Manager (click to expand)
Quality Assurance Manager
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 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, this will drive and champion quality within our organisation.
How to apply
If this role aligns with your capabilities and experience, please submit your resume and a cover letter that addresses the criteria listed above to enquiries@magnetica.com.
Please also include responses to the following questions:
- How many years’ experience do you have as a Quality Assurance Manager?
- Do you have experience working to quality assurance standards?
- How many years of auditing experience do you have?
- Do you have experience managing the development of a product from inception to delivery?
- How many years’ experience do you have in a quality assurance (QA) role?
- Have you completed a qualification in science?
- Have you completed a Good Manufacturing Practice (GMP) training course?
Quality Assurance Associate (click to expand)
Quality Assurance Associate
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.
How to apply
If this role aligns with your capabilities and experience, please submit your resume and a cover letter that addresses the criteria listed above to enquiries@magnetica.com.
Please also include responses to the following questions:
- How many years’ experience do you have as a Quality Assurance Associate?
- Do you have experience working to quality assurance standards?
- Have you completed a qualification in engineering?
- How many years of auditing experience do you have?
- Have you completed a Good Manufacturing Practice (GMP) training course?
- Which of the following Microsoft Office products are you experienced with?
- Do you have experience using Microsoft Word?
We develop and commercialise next generation MRI technologies to provide class-leading solutions to MRI clinicians worldwide.
Approval to work in Australia, UK or USA where roles are based:
Citizen, permanent resident or existing/near-term holder of appropriate visa to be able to work and live in the relevant country preferred.
Interested in joining our team?
Apply here!