Quality Control 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: 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