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.