Medical device specialist

Medical device specialist

Life science jobs

Information

As a QbD medical devices engineer you will be working on several projects within ISO13485 environments or you will help companies achieve their ISO13485 certificate. What are your responsibilities? - You are capable of conducting internal audits regarding ISO13485, Quality management systems, Quality Assurance, … - We count on you for the development of a Standard operating Procedure (SOP), related Work Instructions (WI), forms, checklists, protocols, reports - You are responsible for the tracking and reporting on project deliverables - You are responsible for preparing all documentation for filing to authorities - You follow regulations on medical devices - You support in setting up the timelines for the go-to market strategy in light of the applicable regulations and the customer’s business plan Who are we looking for? - Scientific master’s degree: engineer, industrial pharmacist, … - Experience in the life science industry and in GMP - Knowledge on quality system standards (ISO 13485) or regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR) - First experience with audits What's in it for you? - QbD is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:  - A company with a clear strategy and ambition  - We've got your back! Our HR Business Partners follow you closely, giving you the opportunity to shape your career.  - Thanks to our flat organization, we have short communication lines and you can always come to us.  - With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.  - Teambuilding and fun activities are planned on a monthly basis. Interested? Send your CV and motivation letter to jobs@qbd.eu! Want some more info? https://jobs.qbd.eu/en/vacancies/vacancy-medical-device-specialist/
Quality by DesignQbD is a partner in the development of qualitative and advances therapies and technologies for the benefit of patients and consumers worldwide. Our knowledge and expertise are at our clients’ disposal. We gained this expertise in following main domains: Quality Assurance Validation & Qualification Regulatory Affairs Projectmanagement & Support Within our two focal points (ATMPs and Medical Devices), we want to take on a pioneering role on a global level and help determine the rules in these two fields. In the short and mid long term, we aim to be present in 5 European countries by starting up QbD subsidiaries or via acquisitions. Additional to those, we also aim to have a few subsidiaries in North-America and Asia. It’s QbD’s ambition to: Being present in all continents worldwide Being present in minimum 5 European countries with more than 50 staff members per country Having an active participation in at least one company dealing with ATMPs and one company dealing with medical devices Being a full service knowledge organization with full expertise in:Process development within ATMPs Quality Assurance and Regulatory Medical Devices Artificial Intelligence/Deep Learning Become, with QbD Software, a premium supplier for the life sciences Having CSV outsourcing/off shoring/near shoring on point

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