Quality Engineer - Medical Devices & Regulatory

Materialise; Plymouth (MI); On-site; USD 85,000 - 112,000; Full time

Job summary

Materialise Medical in Plymouth, MI seeks an experienced Quality Engineer to maintain and improve the quality management system for medical software. You will ensure regulatory compliance (FDA/QSR/MDSAP) and ISO 13485, support SOP development, and drive quality through audits, change control, and risk analyses.

You will liaise with regulatory experts, perform internal audits, and push for process improvements while delivering precise documentation and effective corrective actions across the

Qualifications

• Degree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline.
• Experience ISO 13485 and FDA Regulations.
• Understanding of quality practices and documentation.
• Delivery of quality systems in a software environment.
• Knowledge of medical software regulation practices and auditing.
• 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.
• Provide Quality afternoon support for the medical unit; assist with SOP writing, review, and approval.
• Review engineering change orders, non-conformance reports, process qualifications, product disposition, risk and health analyses.
• Provide statistical trend analysis of the quality management system and identify deficiencies.
• Manage verifications/validations of the quality system.
• Liaise with regulatory experts to ensure compliance with standards.
• Identify process improvements and document them through resolution.
• Perform internal audits and organize quality meetings.

Skills

Quality engineering

Regulatory awareness

Software quality

Auditing

Education

Engineering degree

Tools

ISO 13485

FDA Regulations

Job description

Materialise Medical in Plymouth, MI seeks an experienced Quality Engineer to maintain and improve the quality management system for medical software. You will ensure regulatory compliance (FDA/QSR/MDSAP) and ISO 13485, support SOP development, and drive quality through audits, change control, and risk analyses.

You will liaise with regulatory experts, perform internal audits, and push for process improvements while delivering precise documentation and effective corrective actions across the