Quality Engineer - ISO13485 & FDA (Medical Devices)

MAT USA Materialise USA, LLC; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

Materialise Medical in the United States is seeking a Quality Engineer to ensure the quality management system complies with FDA/QSR/MDSAP and ISO 13485. You will support SOP development, review change orders, perform risk analyses and drive CAPAs.

You will liaise with regulatory experts, analyze regulatory docs, and implement improvements in software quality processes. A detail-oriented mindset and strong communication are essential.

Qualifications

• Degree educated in Engineering or a related discipline.
• Experience as a quality engineer managing a quality system (ISO 13485 and FDA).
• Ability to analyze regulatory documentation and implement required changes.
• Strong emphasis on quality, process, and documentation in software environments.
• Familiar with medical software regulation practices and audits.

Responsibilities

• Ensure implementation of the quality management system in line with FDA/QSR/MDSAP and ISO 13485.
• Support quality policy to enhance value, drive innovation, and improve product quality.
• Provide QA support for SOP writing, review, and regulatory compliance.
• Review change orders, non-conformances, risk analyses, and related QA items.
• Perform statistical trend analysis and monitor for process improvements and CAPAs.
• Conduct internal audits and organize quality meetings.

Skills

ISO 13485

FDA Regulations

Quality management systems

Regulatory documentation analysis

Quality in software

Communication skills

Attention to detail

Education

Engineering degree

Job description

Materialise Medical in the United States is seeking a Quality Engineer to ensure the quality management system complies with FDA/QSR/MDSAP and ISO 13485. You will support SOP development, review change orders, perform risk analyses and drive CAPAs.

You will liaise with regulatory experts, analyze regulatory docs, and implement improvements in software quality processes. A detail-oriented mindset and strong communication are essential.