Senior Quality Assurance Expert

6 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $70,000 - $100,000
Quality Management Specialist Job Description

The Quality Management Specialist is responsible for ensuring the quality of products and services by implementing quality assurance processes and procedures. This role involves reviewing product development and manufacturing documentation, providing input on compliance and the quality of project deliverables.

This position requires a strong understanding of quality management systems, including ISO 13485, and experience in undertaking product realization and manufacturing planning, quality control, and process validation in medical device manufacturing environments.

  • Assist the Quality Manager in managing and improving the Quality Management System.
  • Work as the Quality Lead in cross-functional teams, providing guidance and direction on product development activities, ensuring adherence to guidelines and requirements.
  • Review product development and manufacturing documentation to provide input on compliance and quality.

This role offers a unique opportunity to work in a dynamic environment, collaborating with experts to develop high-quality products and services that make a positive impact.

Key qualifications include:

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

If you are a motivated and detail-oriented individual who is passionate about quality and excellence, this may be the perfect fit.

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