Our site in Leuven Belgium is looking for a top notch engineer to support the manufacturing of products in the high tech, aerospace and healthcare industries.
The Quality Engineer is responsible for focusing engineering quality as regulated by the ISO 13485, ISO 9001, AS9100 and global requirements such as FDA QSR, MDD and various aerospace regulations. This position is responsible for supporting the development and execution to establish processes in accordance with the quality system for 3D Systems’ Healthcare, Aerospace and/or Industrial product lines.
• Collaboration with project teams as a contributing member by providing quality and process engineering support in the development of new products and processes, and continuously improving 3D Systems’ products
• Assisting project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485/9001 and other applicable ISO/EN standards
• Application development of new technologies to enhance the capabilities of 3D Systems’
• Contributing to the development and execution of verification & validation plans, testing, and generation of test protocols and reports of processes, equipment and software
• Development and contribution to the risk management process
• Development and contribution of process quality controls and planning
• Participating in the compilation and review of technical documentation for both domestic and international regulatory submissions
• Facilitating and performing internal and supplier QA audits as required
• Participating in the execution, maintenance and improvement of the Quality Management System.
• Analyzing reports and returned products and recommending corrective/preventive actions (CAPAs)
• Leading process improvement initiatives of cross functional teams to address business and quality manufacturing issues
Biomedical Engineering, Chemical Engineering
Biomedical & Pharmaceutical
• A challenging job in a young and dynamic team
• A competitive salary and additional non-statutory benefits
• Career opportunities in a global company with exponential growth
• Bachelor degree, preferably in engineering
• 2-4 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or food manufacture.
• Quality assurance and reliability experience supporting product development and/or manufacturing are preferred.
• Ability to develop, implement and maintain compliant documentation for software validation in accordance with FDA and medical devices software regulations.
• Working knowledge of FDA and ISO 13485 Quality System.
• Ability to read and design engineering specifications across a number of products and materials.
• Ability to analyze and develop quality control engineering processes for use in advanced technology implementations.
• Problem solving team facilitator
• Fluent in English