Quality Engineer R&D
Biocartis NV; email: HR@biocartis.com
- Function Type
- Experience Required
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
Academic level in Molecular Biology, engineering, chemistry, pharmacy or equivalent
- Functional Area
- Travel Percentage
Purpose of the position:
The Quality engineer R&D is responsible to support assay development projects from the quality perspective and is a member of the Menu Development Sphere.
Tasks / outcome domains
To support assay development project teams, both internally and with 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 and Competencies
- 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;
- Advanced knowledge, orally and in writing of Dutch and English;
- Highly accurate;
- Achievement and customer service oriented mindset;
- Able to work autonomously;
- Conceptual thinking;
- Good decision-making skills;
- Hands on mentality;
- Team player who likes to develop others.
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.
Please apply by e-mail (Resume only in English) to HR@biocartis.com using the job ID 2014017 and the job title as a reference.