Quality Assurance Manager
Talentum Connect
Northgate, Brisbane QLD, Australia
Full Time
Hybrid
Required skills
Quality Assurance
Quality Management System (QMS)
ISO 13485:2016
21 CFR Part 820
Medical Devices
MedTech
Biotech
Regulatory Compliance
Internal Auditing
External Audits
CAPA Management
Non-Conformance Management
Corrective Actions
Preventive Actions
Document Control
Design Controls
Clinical Evidence
Product Lifecycle Management
EU MDR
US FDA Regulations
TGA Regulations
NZ Medsafe
510(k) Submission
GMP
Quality Engineering
Problem Solving
Perks & benefits
Permanent full-time opportunity; Hybrid and flexible work arrangements; Opportunity to support innovative MRI medical technology; Direct impact on product commercialisation; Work with global MedTech teams; Career growth within a growing organisation; Collaborative technical environment
Job description
Talentum Connect is recruiting a Quality Assurance Manager for Magnetica, a medical device engineering and technology company specialising in MRI systems, sub-systems and technologies. The role is responsible for leading all quality aspects of the business and driving a strong quality culture across the organisation. The successful candidate will manage and continuously improve the Quality Management System (QMS), ensure compliance with ISO 13485:2016, 21 CFR Part 820 and global medical device regulations, coordinate audits, manage corrective and preventative actions, maintain controlled documentation and support the delivery of regulatory-compliant medical device products throughout the product lifecycle. The position works closely with technical teams, regulatory affairs, production, supply chain and senior leadership to ensure quality excellence during product commercialisation and manufacturing.
Ready to apply?
Create a free candidate account to submit your application for this role. After signup you’ll return here to finish applying.
- View full job details above — no account needed
- Sign up once, then apply in a few steps
- Upload your resume and track applications