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Open nowPosted 23 days ago

QC Engineer, Medical Device Manufacturing #HMZ

MyCareersFuture94,028 open roles

Pay
SGD 4,500 – SGD 6,500 a month
Where
Central, Singapore
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Your applicationOpen nowQC Engineer, Medical Device Manufacturing #HMZMyCareersFuture · Central, Singapore

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This job: posted 23 days ago

The posting

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

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