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High-Tech Product Development Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $70,000 - $100,000
Senior Quality Associate

The IDE Group is a global leader in medtech commercialization. We work with partners to build better futures by creating meaningful outcomes through our values: be resourceful, be curious, think positive, put others first, embrace complexity and take ownership.

We are seeking a Senior Quality Associate who is a proactive, passionate team player, driven by solving complex challenges. The role will involve working in a cross-functional team to provide guidance/direction on product development activities, ensuring adherence to guidelines and the requirements of QMS and best practice design controls.

Key responsibilities include:

  • Reviewing product development and manufacturing documentation to provide input on compliance and the quality of project deliverables being created.
  • Advising on suitable approaches and required documentation as part of regulatory submissions for medical devices.
  • Using product development, commercialization and quality assurance experience to support strategy development, budgeting and planning engineering activities for product development, commercialization and manufacturing projects.
  • Identifying areas where process scaling can be applied to ensure a safe and effective device is developed while optimizing the use of engineering resources within the projects.

The ideal candidate will have a degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline, with 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 and understanding of key Medical Device standards including ISO 14971 and IEC 62366 is also highly desirable.

This is an exciting opportunity to join a dynamic team and contribute to the delivery of high-quality products that make a difference in people's lives.