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:

melanietay@recruitexpress.com.sg

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
Recruit Express Pte Ltd Company Reg. No. 199601303W | EA License Number: 99C4599