Quality Engineer

Materialise • Plymouth, MN

2d

About The Position

At Materialise Medical, the Quality Engineer helps ensure that personalized healthcare solutions are supported by a compliant and effective quality management system. The role supports the medical unit and helps maintain high quality while improving customer value, innovation, infrastructure, knowledge, and product and service functionality.

The position applies regulatory requirements including FDA/QSR and MDSAP, ISO 13485 standards, and customer needs. It involves reviewing and developing quality documentation, investigating and resolving quality issues, analyzing trends, verifying and validating quality systems, coordinating with regulatory experts, conducting internal audits, and organizing quality meetings.

Requirements

• Degree in an engineering, computing, science, medical, or mathematical-based discipline.
• Experience managing a quality system, particularly with ISO 13485 and FDA regulations.
• Ability to analyze regulatory documentation and determine the changes needed for conformity.
• Demonstrated understanding of quality practices and the importance of processes and documentation.
• Experience delivering quality systems in a software environment.
• Knowledge of key medical software regulatory practices and procedures, and associated auditing processes.
• Good communication skills.
• Great attention to detail and a quality-first mentality.

Responsibilities

• Ensure implementation of the quality management system in compliance with regulatory requirements, including FDA/QSR and MDSAP, ISO 13485 standards, and customer needs.
• Support the quality management system and quality policy to maintain high quality and enhance customer value, innovation, infrastructure, knowledge, and product and service functionality.
• Provide quality support for the medical unit, including writing, reviewing, and approving standard operating procedures.
• Review engineering change orders, non-conformance reports, process qualifications, product disposition requests, pre-release product reviews, risk analyses, health hazard analyses, and other quality-related issues.
• Provide statistical trend analysis of the quality management system.
• Monitor, evaluate, and investigate processes to identify potential deficiencies, communicate issues, and initiate corrective actions.
• Manage and monitor deficiencies through resolution and ensure corrective and preventive actions are implemented and effective.
• Review, write, or perform quality system verification and validations.
• Liaise with company regulatory experts to ensure compliance with necessary standards.
• Identify process improvements or breaches, and document and track them through resolution.
• Perform internal audits to ensure the company adheres to its processes.
• Organize and take minutes at necessary quality meetings.

What This Job Offers

• Job Type: Full-time