Job Description

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- Brisbane based candidates, or open to relocate. Permanent opportunity.
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- Opportunity to be an integral part of an expanding global business.
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About Our Client

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We are proud to be representing a global MedTech company dedicated to advancing assisted reproductive technology (ART) and fertility care, as they seek to appoint a Site Director for their production facility in Brisbane.
n Formed by bringing together several industry-leading reproductive health and laboratory technology businesses, Nexpring Health is a global leader in fertility and reproductive health technology, providing innovative solutions that support fertility clinics and healthcare professionals worldwide. With a commitment to improving patient outcomes through science, innovation, and collaboration, Nexpring Health is helping shape the future of reproductive medicine.

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Job Description

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Job Responsibilities:

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- Own and maintain the site Quality Management System (QMS)
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- Serve as site Regulatory lead
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- Interface with regulatory agencies, notified bodies, and auditors
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- Lead internal, and regulatory audits and maintain inspection readiness
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- Manage CAPA, nonconformance, deviation, and complaint systems
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- Oversee validation activities for processes and equipment
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- Track quality and regulatory KPIs (FPY, scrap,



audit results)
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- Ensure labelling, traceability, and documentation compliance
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- Support new product introduction and regulatory submissions
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- Drive root cause analysis and continuous improvement initiatives
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- Develop and lead the Quality & Regulatory team
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The Successful Applicant

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Skills & Experience:

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- Bachelor's degree in Engineering, Quality, Regulatory, or related field (Master's preferred).
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- 7-10 years in highly regulated device manufacturing with 3+ years in leadership roles.
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- Strong knowledge of global regulatory requirements
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- Experience with regulatory submissions and agency interactions
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- Expertise in CAPA, validation, and risk management
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- Strong leadership and communication skills
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- Strong Experience in precision manufacturing
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What's on Offer

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- Competitive salary.
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- Prospect to work in a global organisation.
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- Challenging and rewarding role in a permanent capacity.
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- Chance to lead and influence quality and regulatory standards in a highly regulated manufacturing environment.
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If you're passionate about quality assurance and regulatory excellence, this role is a fantastic opportunity to make a meaningful impact.

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📌 QA & Regulatory Lead - MedTech (Queensland)
🏢 Michael Page Australia
📍 Queensland