I D
Vor 4 Tagen
Published On: December 16, 2024
About IDE Group At IDE we love working with our partners to build better futures, working 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, and our values of being resourceful, curious, thinking positively, putting others first, embracing complexity, and taking ownership to drive successful outcomes.
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 Variety of projects available About the role Based at our office in Leichhardt Sydney Full-time We are seeking a Quality Associate who is a proactive, passionate team player, driven by solving complex challenges.
You'll be comfortable in making decisions based on accurate information, able to apply critical thinking skills, and willing to challenge the status quo.
This role is in our Connected Care Business Unit where you will report directly to the Business Unit Director.
Your primary role will be as the Quality Leader on product development 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 throughout Product Development projects and supporting manufacturing activities.
Key Responsibilities Include:
Work within cross-functional teams providing guidance/direction on product development activities, ensuring adherence to guidelines and the requirements of the device.
Provide guidance on the use of design controls within product development and advise on suitable approaches during development.
Guide employees through new or improved methods to product development, by means of QMS processes.
Review and approval of engineering documentation to provide input on product development activities and direction to employees.
Ensure appropriate engineering principles are applied throughout the development of medical devices by reviewing and analysing product development documentation.
Advise on suitable approaches and required documentation as part of regulatory submissions of devices.
Use of industry experience to support strategy development, budgeting, and planning engineering activities for product development.
Identify areas of scaling during the product development phase 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 in management of key QMS processes including equipment calibration, supplier qualification, and Corrective and Preventive Actions.
Minimum Qualifications:
A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
Minimum 2 years experience working in medical device development projects in a functional leadership 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 manufacturing planning, quality control and process validation in medical device manufacturing environments.
Strong Microsoft Office skills, particularly Word and Excel.
About you Why IDE Career progression and a strong mentoring program Flexible working options available Employee benefits including an employee assistance program Ready to join the team?
If you are ready to be challenged but fulfilled, and have the right skills, experience and, most importantly, the right attitude, then a truly unique role in a life-changing product development company awaits.
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