Senior / QC Specialist (Medical Device | Diagnostics) #HJO

Job Responsibilities • Lead investigation and resolution of product and manufacturing quality issues in collaboration with Production, Manufacturing Engineering and Supplier Quality teams. • Own and drive non-conformance / OOS investigations, root cause analysis and CAPA through timely closure. • Investigate QC laboratory and instrument test failures and connect findings to manufacturing or product quality issues. • Perform hands-on troubleshooting of QC instruments, test methods and laboratory processes. • Monitor QC test yield, process data and quality trends to identify improvement opportunities. • Support customer complaint investigations and failure analysis of returned products. • Support process, method and equipment validation activities and ensure appropriate quality controls are established. • Manage QC laboratory activities, equipment readiness, reagents and testing procedures supporting manufacturing operations. • Work closely with Manufacturing and Engineering teams to implement corrective actions and process/test improvements. • Analyse QC data and prepare quality performance reports for trend analysis and management review. • Drive continuous improvement of QC laboratory practices and manufacturing quality processes. Requirements • Bachelor’s Degree in Chemistry, Biochemistry, Biological Science, Life Sciences or related discipline. • 3–10 years of relevant experience in QC / Quality Engineering within IVD, diagnostics, medical devices, biopharmaceutical or life-science manufacturing. • Strong hands-on experience in a QC laboratory or manufacturing quality environment. • Knowledge and practical understanding of ISO 13485 is required. • Experience with statistical analysis and QC data trending/process improvement. • Familiarity with ERP systems; SAP experience will be advantageous. • Strong analytical, communication and coordination skills with the ability to work independently. Interested candidates are invited to email your resume to: jen.ooi@recruitexpress.com.sg Jenalyn Ooi Huai Sian (R1765551) Recruit Express Pte Ltd Company Reg. No. 199601303W EA Licence No. 99C4599