Senior Manufacturing Process & Quality Engineer

Creative Solutions Services, LLC; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Senior Manufacturing Engineer in Cambridge, MA to develop and optimize manufacturing processes ensuring efficiency, quality, and cost control. The role supports process validation, continuous improvement, and project management while ensuring ISO 9001, ISO 13485, and FDA compliance.

The candidate will lead FAI activities, manage QN in SAP, CAPA, and collaborate with Quality, R&D, and Production teams to implement data-driven improvements using Lean

Qualifications

• Bachelor-level degree required; field relevant to manufacturing.
• Minimum 8+ years of Senior Manufacturing Engineering experience.
• Experience with root cause analysis of production failures and equipment troubleshooting.
• Knowledge of PFMEA/IQ/OQ/PQ and statistical analysis of process data.
• GD&T understanding on mechanical drawings.
• Experience with project management activities.
• Knowledge of operational excellence, Lean, and problem solving.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection activities to ensure product compliance.
• Create and track Quality Notifications (QN) in SAP for nonconformances and defects.
• Manage process deviations and CAPA via SICR.
• Use SAP for production planning, material mgmt, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production to resolve issues.
• Apply Lean and Six Sigma to drive continuous improvement.
• Host meetings, assign action items, and monitor progress.

Skills

Lean

Six Sigma

Project management

Education

BS/BA in Management, Operations, Engineering, or related field

Tools

SAP

Power Apps

Windchill

PDF Writer

MS Office

Job description

Creative Solutions Services, LLC is seeking a Senior Manufacturing Engineer in Cambridge, MA to develop and optimize manufacturing processes ensuring efficiency, quality, and cost control. The role supports process validation, continuous improvement, and project management while ensuring ISO 9001, ISO 13485, and FDA compliance.

The candidate will lead FAI activities, manage QN in SAP, CAPA, and collaborate with Quality, R&D, and Production teams to implement data-driven improvements using Lean