Quality Engineer – Medical Devices (ISO 13485 + FDA)

Materialise NV; Plymouth; Hybrid; GBP 42,000 - 63,000; Full time

Job summary

Materialise Medical in Plymouth is seeking a Quality Engineer to ensure the quality management system complies with FDA/QSR/MDSAP and ISO 13485. You will support SOPs, review change orders and NCMs, perform audits, and drive CAPA actions within a software-enabled medical environment.

The role emphasizes regulatory knowledge, meticulous documentation, and cross-functional collaboration with regulatory experts to maintain top-quality medical software products.

Qualifications

• Degree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline.
• Experience as a quality engineer with ISO 13485 and FDA regulations.
• Ability to analyse regulatory documentation and derive changes to conform.
• 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.

Responsibilities

• Ensure implementation of the quality management system with regulatory compliance (FDA/QSR/MDSAP) and ISO 13485.
• Provide QA support for SOP writing, reviewing and approval to ensure regulatory compliance.
• Review change orders, non-conformance reports, risk analyses and QA issues.
• Perform internal audits and organize quality meetings.
• Liaise with regulatory experts to ensure standards compliance.

Skills

Quality system

ISO 13485

FDA regulations

Regulatory analysis

Software quality

Medical software regulation

Communication skills

Attention to detail

Education

Engineering degree

Computing degree

Science degree

Medical/Mathematical discipline

Job description

Materialise Medical in Plymouth is seeking a Quality Engineer to ensure the quality management system complies with FDA/QSR/MDSAP and ISO 13485. You will support SOPs, review change orders and NCMs, perform audits, and drive CAPA actions within a software-enabled medical environment.

The role emphasizes regulatory knowledge, meticulous documentation, and cross-functional collaboration with regulatory experts to maintain top-quality medical software products.