Quality Assurance Engineer - Temporary
They are a center of excellence for the development of innovative solutions for the surgical ophthalmic market. The center in Groningen is responsible for the design and manufacture of these products.
You work in a multidisciplinary and international team on a broad range of activities, from Quality Management System activities to risk management, CSV and process validation and support. This project will require you to travel between Groningen and Noord-Brabant on a regular basis. This project will last until the end of 2020.
- Lead risk management activities (FMEA)
- Support process validation process (IQ/OQ/PQ/Test Method Validation) via proactive support, and review and approval of documentation.
- Oversee QMS activities per existing plan and support execution (editing QMS document)
- Review and approve project documentation.
- Ensure that the change control procedures are correctly applied
- A relevant Bachelor or Master of Science degree (technical, life science or related);
- At least 5 years of relevant work experience in the medical device industry
- A close loop approach to quality, like working in teams and projects.
- Good working knowledge of medical device regulations (21CFR Part 820 and ISO 13485 and ISO 14971)