Senior Quality System Engineer - Design, Airvo

About the Role

We have an exciting opportunity for a Senior Quality Systems Engineer to join the Design Quality Team supporting our Airvo product group. Working in partnership with our design and development engineering teams, you will provide expert quality guidance and collaborate closely with Product Development to release newly developed products to various markets. You will also support the ongoing conformance and compliance of existing products in their markets. Using your technical and quality expertise, you will ensure robust design assurance for both new and existing products.

Your responsibilities include leading and providing technical oversight for activities related to the use of design controls, driving the implementation and continuous improvement of our Quality Management System (QMS) to maintain compliance, and ensuring product quality to support effective and efficient product commercialisation.

As a Senior Quality Systems Engineer, you will also be responsible for identifying and implementing QMS improvements, acting as a recognised subject matter expert for quality systems, and providing guidance and support across the organisation on QMS-related matters.

Skills & Experience

We are looking for someone with:

Skills and experience required:

• A minimum of 5 years' related work experience in Quality Engineering or a similar technical field.
• Experience in a highly regulated manufacturing and design environment, with medical device experience highly advantageous.
• Strong working knowledge of the regulations that apply to the medical devices industry, with an understanding of electronic-focused regulations preferred.
• Demonstrated experience applying quality principles to support business objectives and product outcomes.
• Experience leading quality initiatives, projects, or complex compliance activities.

You will also have:

• The ability to build strong relationships, influence stakeholders, and work collaboratively across teams, sharing knowledge and providing quality leadership to the Airvo product group.
• Excellent communication skills with the ability to communicate complex concepts, positively influence, negotiate, and challenge constructively with respect and diplomacy.
• Strong problem-solving capability, combining independent judgement with cross-functional collaboration to address complex issues.
• Resilience and the ability to navigate ambiguity while driving quality-focused outcomes.
• A tertiary qualification in Science or Engineering (ideally Industrial, Biomedical or Mechanical).