Quality Assurance Manager

ISO standards, 13485, approvals FDA, TGA etc
QMS CI, Quality Champion
MedTech product, complex systems
About Magnetica
Magnetica is a medical device company specialising in the development and supply of Magnetic Resonance Imaging (MRI) systems, sub-systems, and technologies. We are focused on commercialising our compact MRI systems for dedicated applications, to bring high-quality imaging closer to the patient point-of-care. Headquartered in Brisbane, Australia, we have offices in Abingdon, near Oxford, UK (Scientific Magnetics Ltd) and Houston, USA (Tecmag, Inc.).
Job Description
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 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.
Your essential experience to meet the requirements of the role will 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.
Your existing capabilities and skills will include:
Proven experience of 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.
Accuracy, attention to detail and a focus on task completion (a finisher).
Being self-driven with good time management and prioritisation skills
The ability to successfully collaborate with technical and non-technical staff.
Proven problem-solving abilities and a willingness to learn and apply new skills; and
A flexible approach to dealing with changing priorities and demands.
To be considered, please submit your resume and cover letter (Word format) by selecting the “apply now” function.
Confidential enquiries can be made to Peter Starling, Senior Client Partner, on 07 3305 5830.
#Magnetica