QC Specialist, Medical Devices & Lab Quality

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 45,000 - 61,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD seeks a QC Specialist to support product quality, lab operations and manufacturing quality improvement in a regulated environment. The role collaborates with Production, Engineering and Supplier Quality teams to drive investigations and corrective actions.

The ideal candidate has 3+ years in QC within medical devices or ISO 13485 settings, with hands-on lab experience and knowledge of ISO standards. Singapore-based, on-site role with competitive salary.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Life Sciences or related discipline.
• Minimum 3 years of manufacturing quality control experience in a regulated environment.
• Hands-on exposure to QC laboratory processes preferred.
• Experience with non-conformance management, complaint investigation and process validation.
• Good knowledge of ISO 13485 and/or MDSAP requirements.
• Experience using statistical tools for quality/process analysis; Lean/Six Sigma Green Belt advantageous.
• Lead Auditor certification advantageous.

Responsibilities

• Drive investigation and resolution of product quality issues in collaboration with Production, Manufacturing Engineering and Supplier Quality teams.
• Initiate and coordinate internal and supplier non-conformance reviews to ensure timely disposition and closure of quality notifications.
• Monitor QC test yield and process data, and work with Engineering and Manufacturing teams to identify and implement process or test improvements.
• Participate in customer complaint reviews and failure analysis of returned instruments to verify issues and identify product quality improvement opportunities.
• Establish and maintain process quality control criteria and provide training to QC Technicians where required.
• Monitor product quality, process performance and quality trends, and implement improvement initiatives to support organisational KPI targets.
• Manage QC laboratory activities supporting manufacturing operations and ensure laboratory readiness and compliance.
• Maintain validated laboratory equipment and support basic troubleshooting or coordination of equipment-related issues.
• Review and support process validation activities to ensure appropriate quality controls are established and maintained.
• Support QC instrument testing activities, including reagent management and procedural updates to meet production and delivery requirements.
• Prepare weekly and monthly quality performance reports for trend analysis and management review.
• Identify opportunities to strengthen QC laboratory practices, quality processes and overall operational effectiveness.

Skills

Quality control

Data analysis

Problem solving

Cross-functional collaboration

Communication

Team coordination

Education

Bachelor's in Chemistry/Biochemistry/Life Sciences

Tools

SAP

ERP systems

Job description

RECRUIT EXPRESS PTE LTD seeks a QC Specialist to support product quality, lab operations and manufacturing quality improvement in a regulated environment. The role collaborates with Production, Engineering and Supplier Quality teams to drive investigations and corrective actions.

The ideal candidate has 3+ years in QC within medical devices or ISO 13485 settings, with hands-on lab experience and knowledge of ISO standards. Singapore-based, on-site role with competitive salary.