Product Diagnostic Expert

1 day ago

Sydney, New South Wales, Australia beBeeMolecular Full time $140,000 - $170,000
Product Care and Quality Team Lead

We seek an experienced and proactive leader to oversee product care, improving molecular diagnostic product performance.

Genetic Signatures develops innovative diagnostic technologies for better patient outcomes. We are a manufacturer serving leading laboratories and expanding our diverse team.

The key responsibilities include:

  • Leading the product care process
  • Reviewing complaints and technical support data
  • Conducting investigations and root cause analysis
  • Coordinating lab testing to determine defect sources or user errors
  • Preparing reports and recommending corrective actions
  • Collaborating with cross-functional teams
  • Monitoring trends and reporting on product performance
  • Improving training materials and documentation
  • Integrating lessons learned into design and risk management
  • Participating in quality system activities and audits

Qualifications and experience required:

  • 5+ years of experience in Molecular Diagnostics
  • Knowledge of regulations, processes, products, and technologies
  • Experience in R&D, manufacturing, or post-market support
  • Strong knowledge of IVD regulations and technologies such as PCR, methylation, or molecular biology
  • Understanding of ISO 13485 and related standards
  • Excellent communication and teamwork skills
  • Strong project and stakeholder management skills
  • Bachelor's degree in Molecular Biology, Biotechnology, Biomedical Science, or related field
  • Familiarity with CAPA, post-market surveillance, and complaint handling systems

A competitive salary will be offered commensurate with experience.

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