Senior Quality Associate

At IDE we love working with our partners to build better futures. We have worked on over 500 projects across the medical technology landscape, including in the areas of respiratory care, drug delivery, connected medical devices and point-of-care diagnostics.

Making a difference is what matters to us. We create meaningful outcomes by living our values: be resourceful, be curious, think positive, put others first, embrace complexity and take ownership.

Our engagement surveys over the last 3 years have revealed that our people love working with us for:

• The people - intelligent people, collaborating together in smart ways to bring products to life
• Our purpose - every day we work at IDE is an opportunity to build better futures
• The variety of projects and intellectual challenges

We are seeking a Senior Quality Associate who is a proactive, passionate team player, driven by solving complex challenges,. You’ll be comfortable in making decisions in an environment of uncertainty, be able to apply critical thinking skills and be willing to challenge the status quo. This role is in one of our Commercialisation Business Units where you will report directly to the Business Unit senior manager. Your primary role will be as the Quality Leader on product development and commercialisation projects, proactively ensuring that quality is planned for and implemented in projects, satisfying project stakeholders to produce commercially successful results. You will also assist the Quality Manager in the management and improvement of IDE’s ISO 13485-certified Quality Management System, ensuring that quality requirements are met both in product development and manufacturing activities.

Work as the Quality Lead in cross-functional teams providing guidance/direction on product development activities, ensuring adherence to guidelines and the requirements of IDE’s QMS and best practice design controls.

Review of product development and manufacturing documentation to provide input on compliance and the quality of project deliverables being created. Advise on suitable approaches and required documentation as part of regulatory submissions for medical devices.

Use your product development, commercialisation and quality assurance experience to support strategy development, budgeting and planning engineering activities for product development, commercialisation and manufacturing projects.

Identify areas where process scaling can be applied to ensure a safe and effective device is developed while optimising the use of engineering resources within the projects.

Actively collect, analyse data and information within product development projects and the QMS. Support management of key QMS processes including equipment calibration, supplier qualification, and Corrective and Preventive Actions.

Essential Criteria

• A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
• Minimum 5 years of experience working in product development projects either in product development or quality assurance role.
• Experience working in an ISO 13485-compliant QMS.
• Understanding of key Medical Device standards including ISO 14971 and IEC 62366.

Desired Skills and Experience

• Experience in undertaking product realisation and manufacturing planning, quality control and process validation in medical device manufacturing environments.
• Strong Microsoft Office skills, particularly Word and Excel.

The Benefits

• Career progression and a strong mentoring program
• Employee benefits including an employee assistance program

• Exceptional mentoring program to ensure your career progresses where you want to go
• Flexible working options
• Employee Assistance Program
• Cross-Functional Team
• Social Activities