Role DescriptionIn your role as Quality Assurance manager, you are responsible for a team of ambitious and dedicated quality experts located at two locations. In collaboration with your team, you will make sure that the QMS is compliant and that all required documentation is controlled, involving variations of legislation for the EMEA region. On a daily basis you are responsible for overviewing the Quality strategies and procedures. This concerns creating company strategies and exchange your knowledge across other departments within the company. You will frequently have consultations with the European Quality Director and the VP Quality & Operations. Finally, you will remain contact with internal and external stakeholders such as notified bodies, distributors and end clients.
ResponsibilitiesOn a daily basis your major job is to overview the QA, in which you guide your team members and collaborate to improve the Quality department. Furthermore, you are involved with: • You are responsible for a team of QA inspectors and engineers • On a daily basis you will support and guide the team and overview the QA procedures • Development of strategic plans and implementation tools for the improvement of the Quality Management System • Overview and collect required documentation and legislation in relation to the product specifications • Review and assessment of procedures involving risk and validation management at the manufacturing site • Development of strategic plans and implementation tools for the improvement of the Quality Management System • You will be on track with the latest developments and changes of QA within the Medical Devices sector • Establishment and maintenance of relationships with departments and external stakeholders on a global level • You will negotiate across the company with various parties on behalf of the QA department
Requirements• Bachelor in Life Sciences or equivalent experience • Minimal 3-5 years of experience within QA in a strongly-regulated environment, preferably food or medical devices • Excellent knowledge of quality standards such as ISO 13485, GMP, ISO 14001, ISO14971 • Knowledge of EU and US regulations preferably the MDD and MDR • Excellent leadership and organisational skills • Fluency in Dutch and English • Strong communicator and analytical skills • Critical Scope • Team Player
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.