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.

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Jenalyn Ooi Huai Sian (R1765551)

Recruit Express Pte Ltd

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