Quality Engineer / MES Quality SME

Job description

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. MES Quality Engineer / MES Quality SMEJob SummaryThe MES Quality Engineer serves as the Site Subject Matter Expert (SME) for Manufacturing Execution System (MES) quality processes, ensuring effective deployment, compliance, traceability, and continuous improvement of manufacturing quality controls throughout the product lifecycle. The role acts as the primary interface between Quality, Manufacturing Engineering, IT, Operations, and Customers regarding MES-related quality processes, system controls, and regulatory compliance requirements. The MES Quality Engineer supports site objectives related to quality, operational excellence, process effectiveness, customer satisfaction, compliance, and continuous improvement while ensuring MES systems support manufacturing requirements, electronic DHR integrity, traceability, and risk management. Essential Duties and ResponsibilitiesMES Quality System OwnershipServe as Site SME for all MES quality-related processes and applications. Own and maintain MES quality workflows, process routes, inspection points, and quality data collection requirements. Ensure MES configuration complies with customer, regulatory, and internal quality requirements. Lead MES quality standardization across manufacturing operations. Drive adoption of best practices for electronic manufacturing records management. Traceability & ComplianceEnsure complete product traceability within MES, including:Material Lot Traceability PCB/PCBA Serial Number Traceability Operator Traceability Equipment Traceability Process Revision Traceability DMR Revision Traceability Support compliance with:ISO 13485 FDA 21 CFR Part 820 ISO 9001 IATF 16949 (where applicable) Customer-specific requirements MES Process ControlEstablish and maintain:Process Verification workflows Quality Gates Hold and Release Controls Electronic Device History Records (eDHR) NCR workflows Rework routing controls Process escalation workflows Ensure failed product disposition paths are defined and controlled within MES. Quality Engineering SupportAnalyze MES quality performance metrics and identify improvement opportunities. Support implementation of:APQP PFMEA Control Plan SPC MSA CAPA 8D Problem Solving Root Cause Analysis (RCA) Lead MES-related investigations and corrective actions. Validation & Change ManagementSupport MES validation activities including:IQ OQ PQ CSV (Computer System Validation) Participate in:Engineering Changes MES System Changes New Product Introduction (NPI) Process Validation Activities Continuous ImprovementLead MES process enhancement projects. Identify automation opportunities to improve:Quality Controls Traceability Productivity Data Integrity Develop dashboards and reporting tools for quality monitoring. Audit & Customer SupportSupport customer audits. Support regulatory inspections. Provide MES quality evidence and traceability records. Present MES compliance status to management and customers. Training & LeadershipTrain and mentor users on MES quality processes. Provide guidance to:Quality Engineers Manufacturing Engineers Production Supervisors Operators Develop site competency related to MES quality controls. Key DeliverablesQuality System DeliverablesMES Quality Procedures MES Validation Documentation Electronic DHR Compliance MES Change Control Records Quality Performance DeliverablesQuality Route Verification Reports Traceability Compliance Reports Defect Analysis Reports CAPA Effectiveness Reports Quality Dashboard Metrics Compliance DeliverablesAudit Readiness Regulatory Compliance Support Customer Requirement Traceability DMR Revision Traceability Controls Management & Supervisory ResponsibilitiesReports to Site Quality Manager or Regional Quality Manager. Functions as Site MES Quality SME. Provides technical leadership and mentoring to Quality Engineers, Manufacturing Engineers, and MES users. May lead cross-functional improvement projects. Required Knowledge & SkillsTechnical KnowledgeMES Systems (Shopfloor/MES) Electronic Device History Records (eDHR) Process Validation Computer System Validation (CSV) Traceability Systems NCR and CAPA Management PFMEA & Control Plans SPC and MSA Root Cause Analysis 8D Methodology Leadership CompetenciesStrong analytical skills Change management Cross-functional leadership Training and coaching capability Project management skills Communication and presentation skills Education & ExperienceEducationBachelor's Degree in: Quality Engineering Industrial Engineering Manufacturing Engineering Mechanical Engineering Electrical Engineering PreferredCertified Quality Engineer (CQE) Six Sigma Green Belt / Black Belt Lean Manufacturing Certification ISO 13485 Lead Auditor ExperienceMinimum 5-8 years in: Quality Engineering Manufacturing Engineering MES Implementation Medical Device Manufacturing Electronics Manufacturing Positioning in OrganizationSite Quality Manager ↓ MES Quality SME / MES Quality Engineer ↓ Quality Engineers Manufacturing Engineers Process Engineers Production Supervisors MES Administrators This structure positions the MES Quality Engineer as the owner of MES quality governance, traceability, compliance, validation, and continuous improvement, which aligns well with a medical SMT manufacturing environment and the expectations of a Quality Engineer SME role. 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