Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.
They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.
The site of this project is the center of excellence for the development of innovation solutions for the surgical ophthalmic market, mainly intraocular lenses. It is responsible for the design and manufacture of these products. A project has started to further develop IOL manufacturing technology with a high degree of automation. Therefore, the Quality Department is looking for a Quality Assurance Engineer.
As a Quality Assurance Engineer you will be working in a multidisciplinary and international team on a broad range of activities, from Quality Management System activities to risk management, CSV, process validation and support. This project will require you to travel between the north province of Groningen and the southern province of North Brabant on a regular basis.
You like working in teams and projects and are result driven. Besides that you have a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.
Your main tasks are:
- Leading risk management activities;
- Supporting process validation processes (IQ/OQ/PQ/Test Method Validation) via proactive support, and reviewing and approving of documentation;
- Overseeing QMS activities per existing plan and supporting execution (editing QMS document);
- Reviewing and approving project documentation;
- Ensuring that the change control procedures are correctly applied
- Good knowledge of applicable regulations regarding the development and production of medical devices, in line with the Medical Devices;
- At least five years of relevant work experience preferably in the pharmaceutical or medical device industry;
- A relevant Bachelor or Master of Science degree;
- Preferably working knowledge of validation of Automated / Computerized Systems;
- Knowledge of equipment qualification, process validation, risk management, change control;
- Knowledge of relevant Medical Device regulations;
- Good communicative skills, excellent command of the English language and preferably the Dutch language
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