Quality Engineer

MAT USA Materialise USA, LLC; Massachusetts; Presencial; USD 90.000 - 130.000; Tempo integral

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

ISO 13485

FDA Regulations

Quality management systems

Regulatory documentation analysis

Quality in software

Communication skills

Attention to detail

Formação

Engineering degree

Descrição da vaga

About the role

At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment – helping improve and save lives daily.

Key Responsibilities

• Ensure implementation of the quality management system with compliance with regulatory requirements (FDA/QSR/MDSAP), standards (ISO 13485) and customer needs.
• Assist in supporting the quality management system and quality policy to achieve and maintain the highest level of quality while enhancing value for our customers, driving innovation, growing infrastructure and knowledge and increasing service and product functionality and quality.
• Provide Quality afternoon support for the medical unit, assisting with writing, reviewing and approving standard operating procedures to ensure regulatory compliance.
• Review engineering change orders, non-conformance reports, process qualifications, product disposition requests, pre-release product reviews, risk analysis, health hazard analysis, and quality-related issues.
• Provides statistical trend analysis on the quality management system.
• Monitor, evaluate and investigate processes to identify potential deficiencies, communicate these issues and initiate additional actions to resolve quality-related issues.
• Manage and monitor to ensure deficiencies are resolved and corrective/preventive actions are implemented and effective.
• Reviews, writes or performs quality system verification/validations.
• Liaise with the company regulatory experts to ensure that we comply with any necessary standards.
• Identify process improvements or breaches, document and track them through to resolution.
• Perform internal audits to ensure company is adhering to its processes.
• Organize and minute the necessary quality meetings.

Required Skills & Qualifications

• Degree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline.
• Applicant should be an experienced quality engineer in managing a quality system, with particular experience ISO 13485 and FDA Regulations.
• Ability to analyse regulatory documentation and to derive the necessary changes needed to conform.
• Demonstrated understanding of the importance of quality – including good practices, understanding of the importance of process and documentation.
• Experienced in delivery of quality systems in a software environment.
• Knowledge of key medical software regulation practices and procedures and the auditing processes associated with them.
• Possession of good communication skills.
• Great attention to detail and quality first mentality.

What’s waiting for you

Work that matters The technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it.

No matter your role, we unlock new possibilities to build a better and healthier world every day. At Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.

A people-centered space When you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back. At the same time, we expect you to invest in the people around you — not just your own work — to make the group stronger than the sum of its parts.

An environment of trust As a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls. At Materialise, we expect you to deliver on that trust and keep your commitments.

A career ready to build When you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here. At Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.

Make a difference together with the Medical team. At Materialise, we’re all working towards making the world a better and healthier place every day. And you can be a part of it all! Explore our opportunities to become a part of our team.