Product Care And Quality Team
3 days ago
Product Care and Quality Team (PCQT) LeadNewtown, SydneyWe 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 companyReviewing complaints and technical support data to identify issuesConducting investigations and root cause analysisCoordinating lab testing to determine defect sources or user errorsPreparing reports and recommending corrective actionsCollaborating with cross-functional teams to resolve issuesMonitoring trends and reporting on product performanceImproving training materials and documentationIntegrating lessons learned into design and risk managementParticipating in quality system activities and auditsSupporting senior leadership and other departments as neededQualifications and experience required:Minimum 5+ years of experience in Molecular Diagnostics, with knowledge of regulations, processes, products, and technologiesExperience in R&D, manufacturing, or post-market support within Molecular DiagnosticsStrong knowledge of IVD regulations and technologies such as PCR, methylation, or molecular biologyExperience managing product investigations in regulated environmentsUnderstanding of ISO 13485 and related standardsExcellent communication and teamwork skillsStrong project and stakeholder management skillsBachelor's degree in Molecular Biology, Biotechnology, Biomedical Science, or related fieldFamiliarity with CAPA, post-market surveillance, and complaint handling systemsProficiency with Microsoft Office and quality documentation systemsWe 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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Product Care and Quality Team
2 weeks ago
Sydney, New South Wales, Australia Genetic Signatures Ltd. Full timeProduct Care and Quality Team (PCQT) LeadNewtown, SydneyWe 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,...
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