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Molecular Diagnostic Product Manager

3 weeks ago


Sydney, New South Wales, Australia beBeeProductCare Full time $120,000 - $180,000
Job Overview

The Product Care and Quality Team Lead oversees the product care process, focusing on improving molecular diagnostic products.

This role involves leading and enhancing product care across the company, reviewing complaints and technical support data to identify issues, conducting investigations and root cause analysis, coordinating lab testing, preparing reports, recommending corrective actions, collaborating with cross-functional teams, monitoring trends, and reporting on product performance.

Additionally, this role involves improving training materials and documentation, integrating lessons learned into design and risk management, participating in quality system activities and audits, and supporting senior leadership and other departments as needed.

Qualifications and Experience
  • Minimum 5+ years of experience in Molecular Diagnostics, with knowledge of regulations, processes, products, and technologies.
  • Experience in R&D, manufacturing, or post-market support within Molecular Diagnostics.
  • Strong knowledge of IVD regulations and technologies such as PCR, methylation, or 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, Biomedical Science, or related field.
  • Familiarity with CAPA, post-market surveillance, and complaint handling systems.
  • Proficiency with Microsoft Office and quality documentation systems.