Medical Devices Quality Engineer (ISO 13485 / FDA)

MAT CZE Materialise SRO; Plymouth; On-site; GBP 45,000 - 65,000; Full time

Job summary

Materialise Medical seeks a Quality Engineer to ensure the quality management system complies with regulatory requirements and meets customer needs in a software-enabled medical environment.

You will collaborate with researchers, engineers and clinicians to drive improvements, audits, and SOPs, fostering a patient-centered culture and maintaining high standards across processes and documentation.

Join a trusted team focused on delivering safe, effective solutions that improve lives worldwide.

Qualifications

• Degree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline.
• Experience ISO 13485 and FDA Regulations.
• Ability to analyse regulatory documentation and derive necessary changes.
• Understanding the importance of quality, processes, and documentation.
• Experience delivering quality systems in a software environment.
• Knowledge of medical software regulation practices and auditing processes.
• Good communication skills.
• Great attention to detail and quality-first mentality.

Responsibilities

• Ensure implementation of the quality management system with regulatory compliance (FDA/QSR/MDSAP) and ISO 13485.
• Assist in supporting the quality management system and policy to achieve high quality and value.
• Provide Quality afternoon support for the medical unit, assisting with SOP writing/reviewing/approving.
• Review engineering change orders, non-conformance reports, process qualifications, and risk analyses.
• Provide statistical trend analysis on the quality management system.
• Monitor and investigate processes to identify deficiencies and drive corrective actions.
• Manage and verify that corrective/preventive actions are effective.
• Perform internal audits to ensure adherence to processes.
• Organize and minute quality meetings.
• Liaise with regulatory experts to ensure compliance with standards.
• Identify process improvements or breaches and track to resolution.

Skills

Quality engineering

ISO 13485

FDA regulations

Regulatory documentation analysis

Software quality systems

Auditing

Internal audits

Communication skills

Attention to detail

Education

Engineering/Science/Medical/Mathematical discipline degree

Job description

Materialise Medical seeks a Quality Engineer to ensure the quality management system complies with regulatory requirements and meets customer needs in a software-enabled medical environment.

You will collaborate with researchers, engineers and clinicians to drive improvements, audits, and SOPs, fostering a patient-centered culture and maintaining high standards across processes and documentation.

Join a trusted team focused on delivering safe, effective solutions that improve lives worldwide.