ProClinical is seeking a QA/QC Manager for a blood supply, organisation based in the Netherlands. The QA/QC position will be based in the department 'Reagents', we seek an experienced QA / QC Manager & Qualified Person. It's important that you're good at working together across the boundaries of your own department and easily build and maintain contacts. That you can contribute to the next level of our quality systems required for the preparation and release of laboratory reagents. We are looking for a natural leader with conviction that can properly utilize the years of experience present at the QA / QC department. This is a permanent role.
- A completed university education (medical / biotechnology / biological / pharmacy), preferably with knowledge of immunology and immunohematology;
- minimum 5 years international experience in the in vitro diagnostics / medical devices industry in a leading QA / QC function;
- ample experience with the hierarchical management of employees, the development and motivation of colleagues and teams;
- knowledge of ISO13485: 2016 and ISO9001: 2015 standards, and legislation in the field of medical devices and / or in vitro diagnostics; Experience with US FDA CFR820 (QMS) is a plus;
- experience in implementing quality improvements; experience with product registrations of medical devices and / or in vitro diagnostics; can switch between the strategic and operational level;
- following, analysing and assessing developments in the field of impact and / or usability for the organization;
- the ability to adapt flexibly to new developments and changing priorities;
- Excellent communication skills, including being well-functioning across the boundaries of your own department and maintaining contacts; of course, a good command of the Dutch and English language in word and writing.
- accurate, stress-proof and co-operative.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amber Lakeman on +44 20 3690 593 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.