We are partnering with a fast-growing medical device organisation delivering innovative solutions across a wide & innovative product portfolio. This business is committed to improving patient outcomes through high-quality manufacturing, surgical technologies, and digital health solutions.
Following strategic acquisitions, the organisation is seeking a Quality Assurance Manager to lead the ANZ QA function, with a focus on manufacturing excellence, design transfer, and software validation for new product launches. This role reports to a senior leader based overseas and manages a multi-location team across Australia and overseas.
If you are a self-starter who thrives in a collaborative, fast-paced, and regulated environment, this is an opportunity to make a real impact shaping quality systems, supporting manufacturing and design processes, and improving patient outcomes.
Reporting To Senior Leadership, Your Responsibilities Will Include:
* Lead, coach and develop the QA team, including direct reports in Australia and colleagues overseas.
* Lead design reviews and ensure software and product design transfer activities meet regulatory and internal standards.
* Define and implement standards, methods, and procedures for manufacturing inspection, testing, and evaluation of company products.
* Ensure compliance with ISO 13485 device requirements and other applicable regulations.
* Drive QMS integration for recently acquired businesses, supporting new product launches and agile document control systems.
* Oversee CAPA, root cause analysis, and non-conforming product management across manufacturing and design processes.
* Monitor and report on product quality, manufacturing performance, and design transfer outcomes through management review.
* Serve as the designated Management Representative for quality systems.
* Manage budget, hiring, disciplinary actions, and future leadership responsibilities.
To Be Considered For This Role, You Should Have:
* Demonstrated QMS experience aligned with ISO 13485 (or equivalent), ideally in medical device manufacturing, aerospace, or automotive.
* Proven experience leading and managing QA teams in manufacturing and product design environments.
* Experience operating within developing or non-mature quality systems, driving continuous improvement through influence and leadership.
* Solid understanding of design transfer, software validation, supplier qualification, and regulatory compliance.
* Self-motivated and proactive, capable of operating with minimal oversight.
* Strong communication and stakeholder management skills.
This is an ideal role for a QA leader who wants to drive manufacturing quality, oversee design transfer, and influence strategy while growing within a dynamic global medical technology organisation. You will enjoy leading a collaborative, innovative team and contributing to ambitious growth plans in ANZ and globally.
Applications should be submitted in WORD format, or contact Jasmine Garbino on 0460 947 804 for a confidential discussion.
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