Head of Quality

Multigate; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Free onsite parking

Gym membership

Job summary

Multigate Medical Products seeks an experienced Head of Quality to lead quality, regulatory and compliance functions. This role delivers the company’s quality strategy and oversees QA, QC, regulatory affairs, complaints and non-conformance management to support growth and international expansion.

The Head of Quality will provide strategic leadership for compliance with TGA, ISO 13485 and other standards, manage QMS across operations, and drive audits, validation activities, and governance across

Qualifications

• Demonstrated senior quality leadership in medical devices or regulated manufacturing.
• Experience establishing quality strategies with measurable outcomes.
• Experience managing integrated quality systems across multiple sites and international operations.
• Experience supporting international market expansion and M&A initiatives.
• Strong knowledge of Australian and international regulatory frameworks and quality standards.
• Proven ability to mentor and develop high-performing quality teams.

Responsibilities

• Provide strategic leadership to ensure ongoing compliance with TGA, ISO 13485 and applicable standards.
• Manage an integrated QMS across national and international operations.
• Govern complaints, non-conformances, CAPAs, risk management and post-market activities.
• Lead internal, external, supplier and regulatory audits.
• Oversee medical device validation and sterilisation validation activities.
• Support business growth across multiple markets and advise on international expansion and strategic initiatives.

Job description

Multigate Medical Products is one of Australia and New Zealand's leading manufacturers and suppliers of procedure packs and medical consumables for the public and private hospital markets. For 40 years, Multigate has mastered the growing complexity of Australian healthcare by combining the professional competence of a multinational company with our family-owned company’s virtues and values. Based on our global network of companies, we create solutions to improve our customers’ requirements.

We are seeking an experienced Head of Quality to lead our quality, regulatory and compliance functions. This role is responsible for establishing and successfully delivering the company’s quality strategy and overseeing the Quality Assurance, Quality Control, Regulatory Affairs, complaints and non-conformance management initiatives of the company and its business entities to support long term growth, international expansion and operational excellence.

About The Role

In your role as Head of Quality, you will:

Providing strategic leadership to ensure ongoing compliance with TGA, ISO 13485, and other applicable quality and regulatory standards.

Managing an integrated quality management system (QMS) across national and international operations.

Ensuring successful governance of complaints, non-conformances, CAPAs, risk management and post-market activities.

Leading successful internal, external, supplier, and regulatory audits.

Overseeing medical device validation and sterilisation validation activities.

Managing global quality operations and supporting business growth across multiple markets

Partnering with executive leadership on international expansion, strategic business initiatives, organisational transformation, and merger and acquisition activities.

Building scalable systems, processes, and team capability to support future growth.

Balancing product quality, patient safety, compliance, customer expectations, and commercial outcomes.

About You

To be successful in the role, you will have:

Demonstrated success in a senior quality leadership role within the medical device, healthcare or regulated manufacturing sector.

Experience establishing quality strategies and successfully delivering measurable outcomes.

Experience managing integrated quality systems across multiple sites and international operations.

Success in supporting international market expansion, strategic growth initiatives, and mergers and acquisitions.

Strong knowledge of Australian and international regulatory frameworks and quality standards.

Proven experience building, mentoring, and developing high performing quality teams.

Strong commercial acumen with the ability to assess and optimise total quality cost.

A pragmatic, big picture, outcome focused, strategic leadership style

Strong continuous improvement mindset with the ability to drive organisational change and transformation.

Degree in Science, Biomedical Science, Biomedical Engineering, Medical Technology, Microbiology, or a related discipline.

Experience in sterilisation and advanced qualifications in quality, regulatory affairs, leadership, or business will be highly regarded.

The opportunity to shape long term strategy and have a seat at the table across operations, supply chain and growth planning

Act as the key advisor with direct access to ownershipon matters relating to quality and regulation

Free onsite parking and gym membership

Close to public transport including Yennora train station

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

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

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