Global Quality Assurance Professional
4 days ago
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our QARA team. The successful candidate will have in-depth knowledge of implementing ISO 13485 and/or ISO 9001, as well as familiarity with the regulatory framework of TGA.
About the RoleAs an integral part of the QARA department, you will have the opportunity to work in a hybrid position, reporting to the Quality & Regulatory Affairs Manager ANZ. You will be working in an international, matrix environment, where your key responsibilities will include:
- Managing and leading internal audits for ANZ, adhering to ISO 13485 and ISO 9001 standards.
- Assisting in the preparation of documentation for product registration, tenders, change notifications, and more.
- Assisting with post-market reporting obligations in ANZ, including recall actions and adverse event reporting to regulatory bodies like the TGA and Medsafe.
- Staying up-to-date with relevant regulatory and legal changes and effectively communicating updates to stakeholders.
- Addressing quality or regulatory inquiries from local, regional, and global stakeholders.
This role is ideal for experienced QARA professionals, preferably with an IVD/medical background. To qualify for this position, you should have the following essential requirements:
- A bachelor's degree in a Scientific or Medical field.
- A minimum of 5 years of experience in the medical device, in-vitro diagnostic medical device, or pharmaceutical industries in a technical capacity.
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