Role DescriptionQA Manager consultant for temporary replacement of the current manager.
Responsibilities- Guarantees that the QMS complies with the requirements of the standard ISO27001 and ISO13485 - Modifies the QMS and / or its implementation if deficiencies or non-conformances are detected. - Monitors the performance (Key Performance Indicators) of the QMS and reports this to Top Management, - Takes proper action to correct non-conformances. - Be able to support audits - Keeps the Quality Management System documentation up-to-date. - Monitors the regulatory requirements on medical devices and IVD. - Stay in contact with the certification/ Notified body. - QMS Harmonization projects ( deviations, change controls, non conforming product) - Any additional responsibilities are defined in the applicable Quality Documents - QA releases of software products - Prepares and presents the Monthly quality meeting
Requirements- Bachelor or Master degree in Life Sciences - At least 5 years of experience in a comparable function - Experience in ISO13485:2016 - Knowledge of ISO27001/ 62366/62304 is a pré
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.