Quality Assurance Lead

About the Role:

As the Quality Assurance Lead, you'll be responsible for ensuring the Olympus Sterilisation Service maintains the highest level of compliance with international standards, including ISO 13485, AS 5369:2024, and other relevant regulations.

You'll lead the ongoing improvement of the quality management system, provide quality oversight for batch release of reusable medical devices, and ensure qualification, validation and control of critical sterilisation processes and equipment.

This role is pivotal in ensuring that Olympus continues to deliver safe, effective and compliant sterilisation services to healthcare customers across the region.

Key Responsibilities

• Maintain and continuously improve the Sterilisation Service Quality System to uphold ISO 13485 certification.
• Ensure compliance with AS 5369:2024, ISO 11607, ISO 11135, and global Olympus quality requirements.
• Review and release batches of reusable medical devices in line with Olympus and regulatory standards.
• Support process and equipment validation activities and manage key quality system elements including:
• CAPA, Nonconformance and Change Management
• Risk and Supplier Management
• Training and Document Control
• Internal Audits and Management Reviews
• Post-market surveillance including complaints, product holds, and field actions.
• Report on quality KPIs and maintain dashboards for local, regional, and global stakeholders.
• Provide expert guidance on regulatory and Olympus global quality requirements.
• Support maintenance of ISO 9001 and ISO 14001 certifications for Olympus ANZ.

About Olympus:

At Olympus, our purpose is simple yet powerful, to make people's lives healthier, safer, and more fulfilling. We achieve this through continuous innovation and a deep commitment to improving healthcare outcomes.

As a global leader in medical technology, we design and deliver advanced solutions that empower healthcare professionals to perform diagnostic, therapeutic, and minimally invasive procedures with precision and confidence. Our technologies contribute to better clinical outcomes, reduced costs, and enhanced patient safety and quality of life.

Guided by a strong sense of social responsibility and dedication to our customers, everything we do is driven by our mission to make a lasting, positive impact on society..

Why work at Olympus?

At Olympus, you'll be part of a culture that encourages excellence, collaboration, and innovation. Our shared values, Patient Focus, Integrity, Innovation, Impact, and Empathy, guide our decisions and shape a workplace where every individual can make a meaningful difference every day.

We believe our people are at the heart of our success, and we're committed to helping them thrive through personal growth, recognition, and flexibility.

Here's what you can look forward to:

• Competitive salary package with recognition for high performance
• Learning on Demand - continuous professional development and upskilling opportunities
• Flexible work options, flexible hours, and additional purchased leave
• Health and wellbeing initiatives, such as Corporate Games, Run for the Kids, RUOK Day, free bowel cancer screening, and Employee Assistance Program (EAP)
• Home office allowance for eligible roles
• Reward and Recognition Program - "Shining Stars"
• Dress for your day approach
• Vibrant social culture, including strategy forums, annual awards, and end-of-year celebrations

About You

You are an experienced Quality professional with a strong background in regulated environments and a commitment to operational excellence. You combine technical knowledge with strong analytical and communication skills, enabling you to collaborate effectively across functions.

What you'll bring:

• Tertiary qualifications in science, engineering, or a related field.
• Minimum 3 years' experience in a Quality Assurance role (medical device, pharmaceutical, or related industry).
• Working knowledge of ISO 13485 and/or GMP.
• Experience with sterilisation, infection control, or reprocessing of reusable medical devices (AS/NZS 4187 or AS 5369) highly regarded.
• ISO 13485 Lead Auditor certification desirable.
• Strong attention to detail, initiative, and a collaborative mindset.

Apply Now:

To submit your interest in this opportunity, select "Apply for this job".

Want to know more?

Confidential discussions are welcome; contact our Talent Acquisition Manager - Emma Lucas on A comprehensive Job Description is available on our Careers page.

In the meantime, follow us on:

• LinkedIn - Olympus Australia and New Zealand
• Company website -

"We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply."

No Agency assistance required at this time.