For close to 40 years Multigate has mastered the growing complexity of Australian Healthcare. By combining the professional competence of a multi-national company with our family-owned company’s virtues and values, we have successfully asserted ourselves within the Australian and International healthcare Industries.

We are currently seeking a Quality Assurance Officer to join our team located in our new state of the art facility in Yennora. The role will report to the Senior Quality Manager and is responsible for ensuring document, processes and systems relating to the manufacturing of products at Multigate comply with published specifications and customer expectations.

Role & Responsibilities

Confirm the completeness and accuracy of QMS documentation and vendor published specifications

Undertake performance review of materials and samples associated with local and international suppliers

Maintain assigned aspects of ISO 13485 certification and ensure audit readiness.

Provide training and guidance on quality and regulatory compliance.

Support semi-quantitative risk management and CAPA processes.

Undertake qualification activities associated with critical production processes and supervise the processing of change control workflows

Assist the Quality team with the implementation of Quality and Environmental Management Systems and drive continuous improvement projects

Qualifications and Experience

Demonstrable experience in an equivalent quality role within the medical device, pharmaceutical, manufacturing or similar industry

Proven track record in implementing and maintaining ISO 13485-compliant QMS

Demonstrated success in managing compliance and quality systems

Hands on experience with:

ISO 13485 QMS ownership

Regulatory submissions or ARTG support

Sterile or Class II/III devices





Familiarity with risk management, document control, and audit processes under ISO standards and strong understanding of global medical device regulations (e.g., TGA, APVMA, MDR, MDD)

Competency to read, write and independently interpret quality system documentation including batch documentation, material specifications, test records and quality system standards

Excellent proactive problem solving and written and verbal communication skills

Diploma/Bachelor’s degree in a STEM related or manufacturing preferred

Supportive and collaborative environment

Free onsite gym and parking

Close to public transport including Yennora train station

We live in a changing world, and we need to keep changing with it. Our current look Multigate reflects our improving ability to innovate and better serve you, your patients and our partners.

Since our humble beginnings, Multigate has become known as one of the most respected designers, manufacturers and suppliers of surgical products in Australia.

Today, many of our 2000 plus products are in constant use by surgeons and hospital staff working in the emergency ward, operating theatre and post-op. Our clients choose to use Multigate because we never let them down. They know that our products are manufactured to a level of quality that they can trust, yet are always reasonably priced. More importantly, they know that they can always depend on Multigate to deliver on time.





To be the leader in every category of medical products that we supply through intelligent innovation.

We are the largest designer, manufacturer and supplier of procedure packs in Australia, with a growing team of passionate professionals. However, in a way, Multigate hasn’t changed at all. We are still a company that believes in focusing on our clients’ needs and exceeding their expectations.

Source: This is an extract from the company's own website

Empowering performance since 1986.

We live in a changing world, and we need to keep changing with it. Our new look Multigate reflects our improving ability to innovate and better serve you, your patients and our partners.

Since our humble beginnings, Multigate has become known as one of the most respected designers, manufacturers and suppliers of surgical products in Australia.

Today, many of our 2000 plus products are in constant use by surgeons and hospital staff working in the emergency ward, operating theatre and post-op. Our clients choose to use Multigate because we never let them down. They know that our products are manufactured to a level of quality that they can trust, yet are always reasonably priced. More importantly, they know that they can always depend on Multigate to deliver on time.

To be the leader in every category of medical products that we supply through intelligent innovation.

We are the largest designer, manufacturer and supplier of procedure packs in Australia, with a growing team of passionate professionals. However, in a way, Multigate hasn’t changed at all. We are still a company that believes in focusing on our clients’ needs and exceeding their expectations.

Source: This is an extract from the company's own website

#J-18808-Ljbffr

📌 Quality Assurance Officer (Sydney)
🏢 Multigate
📍 Sydney