QC Engineer, Medical Device Manufacturing #HMZ

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.

Qualified applicants, please email your detailed CV to:

[email protected]

All information will be treated with confidentiality and we regret that only selected candidates will be notified

Consultant: Melanie Tay (Zheng Zhiyuan)
Designation: Division Manager
CEI Reg No: R1104774
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