Product Care and Quality Team (PCQT) Lead
Newtown, Sydney
We are seeking an experienced and proactive Product Care and Quality Team Lead to oversee our product care process, focusing on improving the performance of our on-market molecular diagnostic products.
Genetic Signatures develops innovative diagnostic technologies to improve patient care and outcomes, simplifying molecular pathology. We are an Australian-based manufacturer serving leading pathology laboratories in Australia and distributing worldwide, and we are expanding our diverse, supportive, and talented team.
Key responsibilities include:
* Leading and enhancing the product care process across the company
* Reviewing complaints and technical support data to identify issues
* 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 to resolve issues
* 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
* Supporting senior leadership and other departments as needed
Qualifications and experience required:
* 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
We value diversity and are committed to equal employment opportunities. The successful candidate will receive a competitive salary commensurate with experience.
If you're passionate about making a difference in healthcare and meet the qualifications, we encourage you to apply with your cover letter and CV.
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