Quality Engineer

Onsite, Bourne MA

We are seeking a Quality Engineer with a strong engineering background to support product quality, sustaining engineering, manufacturing operations, and continuous improvement initiatives. This role partners with Engineering, Manufacturing, Supply Chain, and Operations to ensure products and processes meet customer expectations while maintaining compliance with company quality standards. 

The ideal candidate will have experience in quality engineering within a manufacturing environment, strong problem-solving skills, and working knowledge of ISO 9001. Experience with ISO/IEC 17025 and laboratory quality systems is a plus. 

Key Responsibilities 

• Support and maintain the Quality Management System (QMS) in compliance with ISO 9001 requirements. 

• Support sustaining engineering by investigating product and process issues, implementing corrective actions, and driving continuous improvement. 

• Improve product and process quality through root cause analysis, CAPA, data analysis, and process improvement initiatives. 

• Support New Product Introduction (NPI) activities, including design reviews, first article inspections, process validation, and production readiness. 

• Collaborate with Engineering and Manufacturing to improve product quality, reliability, and manufacturing efficiency. 

• Support supplier and customer quality by investigating nonconformances, resolving quality issues, participating in supplier evaluations, and responding to customer concerns. 

• Participate in internal and external quality audits and ensure compliance with customer, regulatory, and quality system requirements. 

• Develop and maintain quality documentation, inspection plans, work instructions, and quality records. 

• Support engineering change activities and ensure quality requirements are effectively implemented. 

Qualifications 

• Bachelor's degree in Engineering or a related technical field. 

• 3+ years of Quality Engineering experience in a manufacturing environment. 

• Experience with ISO 9001 Quality Management Systems. 

• Experience with root cause analysis, CAPA, and continuous improvement methodologies. 

• Knowledge of engineering drawings, GD&T, and technical specifications. 

• Strong analytical, communication, and organizational skills. 

• Experience with ISO/IEC 17025, calibration systems, or laboratory quality management is preferred. 

• ASQ Certified Quality Engineer (CQE), Lean, or Six Sigma certification is a plus.