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Expert in Molecular Diagnostic Product Assurance

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $110,000 - $155,000
Product Quality and Assurance Expert

The Product Quality and Assurance Team Lead plays a pivotal role in ensuring the excellence of our molecular diagnostic products.

Responsibilities include:

  • Strategizing and optimizing the product care process across the company
  • Reviewing complaints and technical support data to identify trends
  • Conducting thorough investigations and root cause analysis
  • Coordinating lab testing to determine defect sources or user errors
  • Preparing detailed reports and recommending corrective actions
  • Collaborating with cross-functional teams to resolve complex issues
  • Monitoring trends and reporting on product performance
  • Improving training materials and documentation
  • Integrating lessons learned into design and risk management

Requirements and qualifications:

  • Minimum 5+ years of experience in Molecular Diagnostics, with knowledge of regulations and technologies
  • Experience in R&D, manufacturing, or post-market support within Molecular Diagnostics
  • Strong knowledge of IVD regulations and technologies such as PCR and molecular biology
  • Experience managing product investigations in regulated environments
  • 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, or related field

Our organization values diversity and is committed to equal employment opportunities. The successful candidate will receive a competitive salary commensurate with experience.