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MES Quality Engineer / MES Quality SME

jabil · Singapore

New
Senior 🇬🇧 English
MES eDHR CSV ISO 13485 IATF 16949 FDA 21 CFR Part 820 PFMEA SPC MSA CAPA 8D

Job description

About the role

Jabil is looking for a MES Quality Engineer who acts as the Site Subject Matter Expert (SME) for Manufacturing Execution System quality processes. The role ensures effective deployment, compliance, traceability and continuous improvement of manufacturing quality controls across the product lifecycle, and is the main link between Quality, Manufacturing Engineering, IT, Operations and customers on MES-related quality issues.

Key responsibilities

  • Own and maintain MES quality workflows, process routes, inspection points and quality data collection requirements, and ensure MES configuration meets customer, regulatory and internal quality needs.
  • Drive MES quality standardization, adoption of best practices for electronic manufacturing records, and full product traceability (material lot, serial number, operator, equipment, process revision, DMR revision).
  • Support compliance with ISO 13485, FDA 21 CFR Part 820, ISO 9001 and IATF 16949 where applicable, and customer requirements.
  • Maintain process verification workflows, quality gates, hold-and-release controls, electronic device history records, NCR workflows, rework routing and process escalation workflows.
  • Analyze quality metrics, support APQP, PFMEA, control plans, SPC, MSA, CAPA, 8D and root cause analysis, and lead MES investigations and corrective actions.
  • Support IQ/OQ/PQ and CSV, and participate in engineering changes, MES system changes, new product introduction and process validation.
  • Lead process improvement projects, identify automation opportunities, and develop dashboards and reporting tools for quality monitoring.
  • Support customer audits and regulatory inspections, provide MES quality evidence and traceability records, and present compliance status to management and customers.
  • Train and mentor Quality Engineers, Manufacturing Engineers, production supervisors and operators on MES quality controls.

Required profile

  • Bachelor's degree in Quality Engineering, Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or Electrical Engineering.
  • Preferred: Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, Lean Manufacturing certification, ISO 13485 Lead Auditor.
  • Minimum 5-8 years in quality engineering, manufacturing engineering, MES implementation, medical device manufacturing or electronics manufacturing.
  • Reports to the Site Quality Manager or Regional Quality Manager and provides technical leadership and mentoring.

Required skills

  • MES systems (shopfloor), electronic device history records (eDHR) and traceability systems
  • Process validation and computer system validation (CSV)
  • NCR and CAPA management, PFMEA and control plans
  • SPC, MSA, root cause analysis and 8D methodology

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Source : ats:workday

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Published 9 hours ago

Expires 1 month from now

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jabil

Singapore