Quality Engineer

Materialise; Plymouth (MI); Presencial; USD 85.000 - 112.000; Tempo integral

Resumo da vaga

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Quality engineering

Regulatory awareness

Software quality

Auditing

Formação

Engineering degree

Ferramentas

ISO 13485

FDA Regulations

Descrição da vaga

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.

Experience

• 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.