Quality Associate

1 week ago

Sydney, New South Wales, Australia IDE Group Full time
Overview

IDE Group is dedicated to creating meaningful MedTech ventures. We partner with clients on projects across the medical technology landscape, including respiratory care, drug delivery, connected devices, and point-of-care diagnostics.

Our values guide our work: Be Resourceful, Be Curious, Think Positive, Put Others First, Embrace Complexity, and Take Ownership.

The Role

Quality Associate

You will apply your knowledge and skills to support IDE in carrying out its mission by:

  • Carrying out the objective of the Quality Functional Group at IDE by continuously improving IDE's Quality Management System.
  • Championing quality throughout the organisation and ensuring work is executed with a high degree of technical excellence for IDE and its clients, satisfying project stakeholders in support of commercially successful results.
  • Working with business units and other IDE functional groups and stakeholders to maintain IDE's ISO 13485 Certification and to develop and enhance IDE's technical and quality management capabilities.
Qualifications & Experience
  • A degree in Industrial Design, Mechanical Engineering, Mechatronic Engineering, Biomedical Engineering, or similar applicable technical discipline.
  • 2+ years of experience in or exposure to Medical Device Development processes and Quality Management Systems such as ISO 13485, ISO 9001, or similar.
  • Experience with electro-mechanical systems, medical devices, consumer products, or technical products (high and low volume).
  • Experience in multi-disciplinary, project-based R&D environments with collaboration across design problems.
  • Experience in project management, reviewing outputs from technical personnel in a cross-disciplinary team.
  • Experience in internal and supplier audits.
  • Experience in risk management and risk analysis activities, including Hazards Analysis and FMEA.
  • Experience in auditing and quality control in medical device manufacturing environments.
  • Strong Microsoft Office skills, particularly Word and Excel.
The Benefits
  • Career progression opportunities and a mentoring program
  • A collaborative, purpose-driven culture with smart, passionate colleagues
  • Access to Employee Assistance Program and wellbeing initiatives
  • Exposure to diverse MedTech projects with real-world impact

If you're ready to apply your quality expertise to meaningful MedTech projects that improve lives, apply to IDE Group to help build better futures.


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