Role DescriptionAs a QA Engineer you have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Devices Regulation, 21CFR Part 820 and ISO 13485 and ISO 14971.
You have a close loop approach to quality, like working in teams and projects, are result driven, while having a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.
Responsibilities• Support the key quality representative in multidisciplinary team working on a process development project, ensuring compliance. Review and approve project documentation; • Ensure correct validation processes application (IQ/OQ/PQ/Test Method Validation) via proactive support, and review and approval of documentation; • Support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques; • Ensure that the change control procedures are correctly applied;
Requirements• At least 5 years of relevant work experience preferably in the pharmaceutical or medical device industry; • A relevant Bachelor or Master of Science degree (technical, life science or related); • Working knowledge of validation of equipment/processes is a must; • Working knowledge of Computerized systems, statistics, risk management, change control a strong plus; • Knowledge of relevant Medical Device regulations (GMP, MDR, QSR CFR 820, ISO 13485, ISO 14971) is considered a strong plus; • Self-starter, result driven, able to function independently as well as in a team; • Able to work towards sound solutions in complex or seemingly conflicting situations; Flexibility and accuracy; • Good communicative skills, excellent command of the English language and preferably the Dutch language; • Knowledge of MS Office;
Other informationFull time preferred, 32 hours minimal. Work location mostly Eindhoven with a trip to Groningen once every fortnight. English required, Dutch considered a plus. Please include a motivation letter. Role is fixed-term (project based).
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.