Senior / QC Specialist (Medical Device | Diagnostics) HJO

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Recruit Express Pte Ltd invites a QC/Quality Engineer to lead investigations of product and manufacturing quality issues, drive non-conformance and CAPA closures, and connect QC findings to manufacturing.

You will perform hands-on troubleshooting, analyze QC data, support supplier and customer investigations, and ensure ISO 13485 compliance with ERP/SAP supported processes.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, life sciences or related discipline.
• 3–10 years of QC/Quality Engineering experience in IVD/medical devices/manufacturing.
• Experience with ISO 13485 and QC data analysis.
• Familiarity with ERP/SAP.
• Strong analytical, communication and coordination skills.
• Ability to work independently.

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.

Skills

Analytical skills

Communication

Coordination

Education

Bachelor’s Degree in Chemistry/Biochemistry/Life Sciences

Tools

SAP

Job description

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.