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Lead Quality Expert

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Sydney, New South Wales, Australia beBeeQualityLeader Full time $70,000 - $100,000

Job Title: Senior Quality Associate

">Quality Lead in Product Development and Commercialisation Projects

This role involves providing guidance and direction on product development activities to ensure adherence to guidelines and the requirements of the QMS and best practice design controls. The incumbent will also be responsible for reviewing product development and manufacturing documentation to provide input on compliance and quality.

  • Provide quality leadership in cross-functional teams to ensure that products meet regulatory requirements and are commercially successful.
  • Review and approve product development and manufacturing documentation to ensure compliance with company policies and procedures.
  • Advise on suitable approaches and required documentation as part of regulatory submissions for medical devices.

Key Responsibilities:

Key Performance Indicators (KPIs):

  • Project deliverables are met within agreed timelines.
  • Product quality is consistently high and meets regulatory requirements.
  • Processes are optimized and scaled to ensure safe and effective device development.

Requirements:

  • Bachelor's degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar 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.