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Quality regulatory affairs specialist

Melbourne
beBeeRegulatory
Quality
Posted: 20 December
Offer description

Medical Device Quality Assurance Role

Austramedex Group operates two complementary medical device manufacturing businesses: a consumables and contract manufacturing business. We are a trusted partner for healthcare professionals and patients across Australia, serving with a large variety of products/solutions.


The Opportunity

We're seeking an experienced Medical Device Quality Assurance Specialist to join our team on a part-time basis. You'll play a critical role in managing quality standards and regulatory compliance across our operations, ensuring our consumables, contract manufacturing products meet the highest quality and safety standards while maintaining full compliance with Australian regulations.


The Role

* Overseeing the quality management system, ensuring consistency with ISO 13485 standards and company policies.
* Assisting production schedules to optimise efficiency while maintaining quality standards.
* Maintaining comprehensive quality documentation and ensuring adherence to manufacturing standards and regulatory requirements.
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