Quality Engineer Medical R&D

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

Are you passionate about 3D printing and do you want to help us to create a better and healthier world with it? Are you driven by Quality and Improvement? Then it is you we are looking for to join the Materialise medical team as Quality Engineer R&D!

Responsibilities

As a Quality Engineer

  • You will report to the Medical Quality Manager and are part of the Quality department in the Medical Business Unit. This department is responsible for the Quality Assurance during the entire life cycle of our medical devices, in a quality system that meets the requirements of ISO 13485 and global regulatory requirements such as FDA QSR.
  • In this function, you will be responsible for Quality Assurance of our products during development phase and for development related aspects during post-market surveillance.
  • Together with Development management in the Medical Business Unit, you drive continuous improvement and are accountable for the compliance of the medical device Development processes, this to ensure innovative, safe and effective products can be made available to patients. 

o    In this exercise, you assist with writing, reviewing and approving standard operating procedures/work instructions and forms to ensure regulatory compliance.
o    You manage CAPA projects to ensure appropriate corrective and preventive actions are implemented to correct design issues and improve the development process
o    You demonstrate compliance of the development processes during audits and inspections by our Notified Body, customers and Regulatory Authorities

  • You are responsible for the quality assurance during development projects, including:

o    Design review: Participate in and approve the outcome of regular multi-discipline review of the design in development
o    Design History File review: Confirm the design documentation is compliant with internal procedures and applicable regulations
o    Design Risk management: Participate in and approve the outcome of design risk analysis

  • You ensure your internal clients in the Development department are performing according to the GMP and the standards in our Quality Management System by:

o    Helping Development management to identify competence and training gaps
o    Organizing and leading audit and inspection readiness initiatives, including training and mock-up audits

Requirements

  • You have previous experience working in a quality role. You are passionate about quality and continuous improvement and strongly care about patient safety and the satisfaction of our end customer, the surgeon.
  • You have a master degree in a technical or medical related field.
  • Previous experience in working with medical standards (ISO 13485, ISO 14971) and medical regulations (FDA QSR, MDD/MDR) is a plus.
  • You have a high interest in R&D activities in a medical environment
  • You have good communication skills and can interact with internal stakeholders to explain and position a strong quality mindset. You can build strong relationships with these internal stakeholders.
  • You have a proactive mindset and take action when you notice issues or opportunities for improvement.

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