Location: Sydney, NSW (Hybrid or Office-based) Employment Type: 12-Month Parental Leave Contract (Full Time), Potential to Extend About Company
We are a small but highly capable and well-established orthopaedic medical device company, supported by a close-knit and experienced team. We are certified in the design, sales, and distribution of orthopaedic implants and instruments, as well as a range of consumable products.
We are seeking an experienced Quality Manager to lead our ISO 13485 Quality Management System during a 12-month parental leave period, with the opportunity to extend. This role combines operational quality management and delivery of a key project: migration from our current eQMS to a new bespoke system. This is a hands‐on role suited to someone who can step in confidently, maintain compliance seamlessly, and drive structured improvement.
The Role
You will oversee and continuously improve our ISO 13485 compliant QMS. In parallel, you will drive the structured migration from our existing electronic QMS to a new fit‐for‐purpose bespoke platform.
Key Responsibilities: Quality Management (ISO 13485)
* Maintain and enhance the ISO 13485 compliant QMS
* Manage internal audits and external audits
* Oversee CAPA, complaints, nonconformance, change control and risk management
* Ensure supplier qualification, monitoring, and review
* Oversee incoming inspection, traceability and distribution controls
* Ensure ongoing compliance with TGA and other applicable regulatory requirements
eQMS Migration Project
* Lead end-to-end migration from the current eQMS to a bespoke platform
* Define business and regulatory system requirements
* Map and optimise existing quality processes prior to migration
* Oversee computer system validation activities
* Manage data migration, testing, training and implementation
* Drive adoption and continuous improvement post-implementation
About You
You are structured, pragmatic and comfortable operating in a regulated medical device environment. You can balance day-to-day quality management with delivery of a defined systems project.
* 5+ years' experience in medical device quality management
* Strong working knowledge of ISO 13485
* Experience managing audits and inspections
* Experience supporting design control and supplier management
* Hands‐on experience with eQMS platforms
* Experience in computer system validation
* Experience with sterile implantable devices
* Experience in distribution-focused medical device businesses
* Experience leading a QMS implementation or system migration
* Familiarity with TGA regulatory framework
* Degree in engineering, science or related discipline
Why Join Us
* Clear, defined leadership role with meaningful responsibility
* Opportunity to modernise and strengthen our quality infrastructure
* Direct exposure to senior leadership
* Potential for contract extension
If you are looking for a structured, impactful contract role within the orthopaedic sector, we would welcome your application.
Please submit your CV and a brief cover letter outlining your relevant experience to
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