MES Quality Engineer / MES Quality SME

Job Summary

The 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 Responsibilities

MES Quality System Ownership

• Serve 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 & Compliance

• Ensure 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 Control

• Establish 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 Support

• Analyze 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 Management

• Support 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 Improvement

• Lead 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 Support

• Support customer audits.
• Support regulatory inspections.
• Provide MES quality evidence and traceability records.
• Present MES compliance status to management and customers.

Training & Leadership

• Train 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 Deliverables

Quality System Deliverables

• MES Quality Procedures
• MES Validation Documentation
• Electronic DHR Compliance
• MES Change Control Records

Quality Performance Deliverables

• Quality Route Verification Reports
• Traceability Compliance Reports
• Defect Analysis Reports
• CAPA Effectiveness Reports
• Quality Dashboard Metrics

Compliance Deliverables

• Audit Readiness
• Regulatory Compliance Support
• Customer Requirement Traceability
• DMR Revision Traceability Controls

Management & Supervisory Responsibilities

• Reports 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 & Skills

Technical Knowledge

• MES 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 Competencies

• Strong analytical skills
• Change management
• Cross-functional leadership
• Training and coaching capability
• Project management skills
• Communication and presentation skills

Education & Experience

Education

• Bachelor's Degree in: Quality Engineering Industrial Engineering Manufacturing Engineering Mechanical Engineering Electrical Engineering

Preferred

• Certified Quality Engineer (CQE)
• Six Sigma Green Belt / Black Belt
• Lean Manufacturing Certification
• ISO 13485 Lead Auditor

Experience

• Minimum 5-8 years in: Quality Engineering Manufacturing Engineering MES Implementation Medical Device Manufacturing Electronics Manufacturing

Positioning in Organization

Site 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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