At a Glance
- Tasks: Lead quality, regulatory, and compliance functions in a dynamic medical products company.
- Company: Join Multigate Medical Products, a trusted leader in surgical supplies across Australia and New Zealand.
- Benefits: Enjoy free onsite parking, gym membership, and a supportive work environment.
- Other info: Be part of a passionate team dedicated to innovation and client satisfaction.
- Why this job: Shape the future of healthcare by ensuring top-notch quality and safety standards.
- Qualifications: Proven experience in quality leadership within the medical device or healthcare sector.
The predicted salary is between 121500 - 148500 $ per year.
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
- 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
- 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 ownership on matters relating to quality and regulation. Free onsite parking and gym membership. Close to public transport including Yennora train station.
Head of Quality in Sydney employer: Multigate
At m|devices, we pride ourselves on being a supportive and innovative employer in the healthcare sector, offering a competitive base salary, uncapped commission structure, and a strong focus on employee growth. Our collaborative work culture encourages professional development and fosters strong relationships with clients, making it an ideal environment for those looking to make a meaningful impact in the medical devices field. Located in Queensland, our team is dedicated to advancing healthcare while ensuring that our employees feel valued and empowered in their roles.
