QC Specialist (Perm) – Medical Device Industry # HMZ

QC Specialist, Medical Device Industry

Employment Type: Permanent
Salary: S$4,000 – S$5,500 per month (Depending on last drawn and experience)

An established medical device and life sciences manufacturer is seeking a QC Specialist to support product quality, laboratory operations and manufacturing quality improvement. This role is ideal for candidates with hands-on QC experience in a regulated manufacturing environment who are comfortable investigating quality issues, reviewing process trends and working closely with Production, Engineering and Supplier Quality teams.

Job 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.

Who Should Apply

• QC professionals with at least 3 years of experience in a regulated manufacturing environment, particularly medical devices, diagnostics or other ISO 13485-controlled operations.
• Candidates with practical experience in non-conformance management, process validation, complaint investigation and QC laboratory operations.
• Individuals who enjoy solving recurring quality problems through data analysis, cross-functional collaboration and process improvement.

Requirements

• Min. Bachelor’s Degree in Chemistry, Biochemistry, Life Sciences or a related discipline.
• Minimum 3 years of manufacturing quality control experience within a regulated environment.
• Hands-on exposure to QC laboratory processes is preferred.
• Experience in non-conformance management, customer complaint investigation and process validation.
• Good knowledge of ISO 13485 and/or MDSAP requirements.
• Familiarity with Good Laboratory Practice and appropriate handling and disposal of biohazard materials.
• Experience using statistical tools for quality or process analysis.
• Lean / Six Sigma Green Belt certification will be advantageous.
• Lead Auditor certification will be advantageous.
• Experience using ERP systems is preferred; SAP exposure will be an advantage.
• Strong problem-solving, communication, interpersonal and coordination skills.
• Self-motivated, detail-oriented and able to work independently with minimal supervision.

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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