Head of Quality

Multigate Medical Products; Sydney; On-site; AUD 180,000 - 260,000; Full time

Benefits offered by this job

Free onsite parking

Gym membership

Close to public transport

Job summary

Multigate Medical Products, a leading Australian medical devices manufacturer, seeks a Head of Quality to steer quality, regulatory, and compliance across national and international operations. You will shape the quality strategy, manage QA/QC, complaints, CAPAs, and audits, and drive post-market activities to enable growth.

You will lead scalable QMS, ensure TGA and ISO 13485 alignment, and partner with leadership on expansion, transformation, and mergers.

Qualifications

• Senior quality leadership experience in medical devices or regulated manufacturing.
• Experience establishing quality strategies with measurable outcomes.
• Experience managing integrated quality systems across multiple sites and international operations.
• Proven track record in supporting international market expansion and growth initiatives.
• Strong knowledge of regulatory frameworks and quality standards.

Responsibilities

• Provide strategic leadership to ensure ongoing compliance with regulatory standards (e.g., TGA, ISO 13485).
• Oversee an integrated quality management system across national and international operations.
• Govern complaints, non-conformances, CAPAs, risk management and post-market activities.
• Lead internal, external, supplier, and regulatory audits.
• Oversee validation activities and global quality operations to support growth.

Skills

Quality leadership

Regulatory compliance

Quality systems

Audits

Strategic thinking

Education

Science degree

Biomedical Science

Biomedical Engineering

Medical Technology

Microbiology

Tools

QMS software

Regulatory databases

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