Senior Quality Engineer

Senior Quality Engineer – Medical Device Industry - Boston

We are seeking a Senior Quality Engineer to provide quality leadership and oversight within a regulated medical device manufacturing environment. This role is responsible for ensuring compliance with FDA and ISO requirements while driving continuous improvement, product quality, and operational excellence.

The Senior Quality Engineer will play a key role in supporting quality systems, CAPA activities, supplier quality, and internal/external audit programs, while partnering cross-functionally with Operations, Engineering, and Regulatory teams.

Responsibilities

• Provide leadership in the development, implementation, and continuous improvement of Quality Engineering systems and practices
• Support CAPA investigations, including root cause analysis, corrective actions, and effectiveness checks
• Oversee non-conforming material processes and participate in MRB activities
• Lead and support internal and external audits, ensuring compliance with applicable regulatory requirements
• Manage and support supplier quality programs, including qualification and performance monitoring
• Develop and maintain quality specifications, inspection plans, test methods, and related procedures
• Provide technical guidance to Quality Control teams to improve inspection processes and efficiency
• Drive initiatives to improve product quality, reduce cost of quality, and optimize processes
• Ensure compliance with FDA, ISO 13485, and applicable regulatory standards
• Support and lead departmental initiatives and cross-functional quality projects
• Provide coaching, training, and performance support to quality team members

Qualifications

• Bachelor’s degree in Engineering or a scientific discipline
• Strong working knowledge of medical device quality systems (FDA 21 CFR Part 820, ISO 13485, and related standards)
• Experience in Quality Engineering within a regulated manufacturing environment
• Strong understanding of engineering drawings, GD&T, and inspection methodologies
• Experience with CAPA systems, audits, and supplier quality processes
• Strong analytical, problem-solving, and documentation skills
• Excellent communication and collaboration skills across all organizational levels
• Proficiency in Microsoft Office, with strong Excel capability