We are looking for a Quality Engineer with expertise in the field of quality assurance in the development of In Vitro Diagnostic products and services. Your role is to contribute to the development of IVD Medical Devices, in order to assure that the development process and product design meet regulatory and customer (quality) requirements and results in products that are safe and effective for their intended use.
• As a member of multidisciplinary R&D project teams, assure that products and manufacturing processes are developed in accordance to the requirements of the QMS.
• Advise management about development milestone passing, release of products for formal verification and validation, release of products for clinical tests and release of final product and manufacturing process design for commercial delivery.
• Support the project leaders and project team members in applying design control rules and QMS processes and procedures.
• Organize and facilitate Product Risk Management based on ISO-14971.
• Establish the Product Quality Plan, contribute to its execution and report the status at milestones and product release moments.
• Participate in the development problem handling and change control to assure that problems and design changes are adequately analyzed, solved, verified, released and documented.
As Quality Engineer you deal with Project Managers, Manufacturing, QC, Customer Support, Marketing, Suppliers and Regulatory Affairs. You report to the Director Quality & Regulatory.
Bachelor or Master degree in area's relevant for IVD's (e.g. biochemistry or molecular biology)
• Relevant work experience in development or quality assurance/control of IVD assay's
• Knowledge of IVD product creation and manufacturing process development methods & tools
• Experience with the application of the ISO-14971 Risk Management standard
• Knowledge of or experience with IVD Medical Device Quality Management Systems based on ISO-13485 and FDA Quality System Regulation is preferred
• Excellent skills in communicating and reporting, both in writing and oral
• Team player, analytical and persistent and able to work in highly dynamic multidisciplinary environment
If this is the position for you , please contact our accountmanager Jerphaas de Hoogh (jerphaas.de.Hoogh@ajilon.nl 0652367347) Please send a motivation letter in english with your application.