Quality Control Engineer, Medical Device Manufacturing #HMZ

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore is seeking a QC Engineer to support product quality, laboratory operations and continuous improvement in an ISO 13485-regulated medical device environment. The role focuses on hands-on investigation with Engineering and Manufacturing teams, not just routine testing.

You will investigate quality issues, monitor test yields, support supplier and customer investigations, and drive process improvements to meet KPI targets.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Life Sciences or a related discipline.
• Minimum 3 years of manufacturing Quality Control experience within a regulated environment.
• Experience in medical device, diagnostics or ISO 13485-regulated manufacturing is advantageous.
• Hands-on exposure to QC laboratory operations and equipment.
• Experience handling non-conformances, investigations, and customer complaints.
• Familiarity with ISO 13485/MDSAP and Good Laboratory Practice.
• Experience with process validation and quality controls.
• Strong analytical and problem-solving skills with good communication.

Responsibilities

• Investigate and resolve product quality issues together with Production, Manufacturing Engineering and Supplier Quality teams.
• Coordinate internal and supplier non-conformance investigations, ensuring timely disposition and closure of quality notifications.
• Monitor QC test yield, process performance and quality data to identify trends and improvement opportunities.
• Support customer complaint investigations and failure analysis of returned products or instruments.
• Establish and maintain process quality control criteria and provide technical guidance or training to QC Technicians.
• Drive quality and process improvement initiatives in support of operational and quality KPI targets.
• Manage day-to-day QC laboratory activities and ensure the laboratory remains compliant and operationally ready.
• Maintain validated laboratory equipment and support basic troubleshooting or coordination of equipment issues.
• Review and support process validation activities to ensure appropriate quality controls are established.
• Support QC instrument testing activities, including reagent management and updates to testing procedures.
• Prepare weekly and monthly quality performance reports for trend analysis and management review.
• Identify opportunities to strengthen QC laboratory practices, quality systems and manufacturing effectiveness.

Skills

Analytical

Problem-solving

Communication

Stakeholder management

Hands-on investigation

Cross-functional collaboration

Education

Bachelor's in Chemistry

Bachelor's in Biochemistry

Bachelor's in Life Sciences

Tools

SAP

ERP Systems

Job description

QC Engineer - Medical Device Manufacturing

Location: East
Employment Type: Permanent

An established medical device manufacturing MNC is seeking a QC Engineer to support product quality, laboratory operations and continuous improvement activities. This role suits an experienced QC professional who is comfortable investigating quality issues, working cross-functionally with Engineering and Manufacturing teams, and driving improvements within an ISO 13485-regulated environment.

Job Responsibilities

• Investigate and resolve product quality issues together with Production, Manufacturing Engineering and Supplier Quality teams.
• Coordinate internal and supplier non-conformance investigations, ensuring timely disposition and closure of quality notifications.
• Monitor QC test yield, process performance and quality data to identify trends and improvement opportunities.
• Support customer complaint investigations and failure analysis of returned products or instruments.
• Establish and maintain process quality control criteria and provide technical guidance or training to QC Technicians.
• Drive quality and process improvement initiatives in support of operational and quality KPI targets.
• Manage day-to-day QC laboratory activities and ensure the laboratory remains compliant and operationally ready.
• Maintain validated laboratory equipment and support basic troubleshooting or coordination of equipment issues.
• Review and support process validation activities to ensure appropriate quality controls are established.
• Support QC instrument testing activities, including reagent management and updates to testing procedures.
• Prepare weekly and monthly quality performance reports for trend analysis and management review.
• Identify opportunities to strengthen QC laboratory practices, quality systems and manufacturing effectiveness.

Who Should Apply

• QC professionals from medical device, diagnostics, biomedical or other highly regulated manufacturing environments.
• Candidates who enjoy hands-on investigation work and working closely with Manufacturing and Engineering rather than purely performing routine laboratory testing.
• Individuals with good knowledge of ISO 13485, non-conformance investigation, complaint handling and process validation who are ready to take greater ownership of product quality.

Requirements

• Bachelor's Degree in Chemistry, Biochemistry, Life Sciences or a related discipline.
• Minimum 3 years of manufacturing Quality Control experience within a regulated environment.
• Prior experience within medical device, diagnostics or ISO 13485-regulated manufacturing will be highly advantageous.
• Hands-on exposure to QC laboratory operations and laboratory equipment.
• Experience handling non-conformances, quality investigations, customer complaints and/or failure analysis.
• Exposure to process validation and manufacturing quality controls.
• Good working knowledge of ISO 13485 and/or MDSAP requirements.
• Familiarity with Good Laboratory Practice and appropriate handling of biohazard materials.
• Experience using statistical tools for quality or process analysis.
• SAP or other ERP system experience is advantageous.
• Lean / Six Sigma Green Belt and/or Lead Auditor certification will be advantageous.
• Strong analytical, problem-solving, communication and stakeholder-management skills.