Biocartis B

QA Engineer R&D (BB-D907E)

Trouvé dans: Xpatjobs BE

Description:
The Quality engineer R&D is responsible to support assay development projects from the quality perspective. Accountabilities To support assay development project teams, both internally and external development partners To provide input from a quality and compliance perspective; To support the creation of qualification and validation documents in relation with assay projects; To review project documentation, mainly DHF; To own the risk management process within the assay project; To ensure assay-dependent issues, deviations and design changes are adequately investigated and documented; To establish and maintain an adequate quality mindset in the assay projects; To provide generic QA support to Menu Development Contribute to equipment, method and supplier qualifications; Contribute to continuous process improvements and to support the SOP creation or updates; Contribute to event and change management related to Menu Development: ensuring that assay-independent issues, deviations and changes are adequately assessed, investigated and documented; To participate in company-wide QA support such as performing internal audits Profile requirements Academic level in Molecular Biology, engineering, chemistry, pharmacy or equivalent; Preferably > 2 years of experience in healthcare industry, preferably in QA; Preferably experience in the medical devices and/or in the IVD industry; Knowledge on ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP; Ability to effectively interact with the project leader and the technical assay development lead when representing the Quality domain Skills: Highly accurate, Achievement Orientation, Customer Service orientation, Conceptual thinking, Decision-making, Hands on, Developing others, Team Player; Languages: advanced knowledge, orally and in writing of Dutch and English; PC skills: MS Office;Electronic Document Management System (MasterControl);Quality Event Monitoring System (MasterControl). Our offering We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

calendar_todayil y a 2 jours

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location_on Mechelen , Flanders, Belgique

work Biocartis

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