QUALITY & PRODUCTION COORDINATOR (M/W) - ISO 9001 – 13485 – 17025 - CE IVD MDR & MEDDEV Standards
30+ days ago
As Head of Quality Steering Committee, you are involved in the development of our quality assurance policy.
You verify the compliance of our activity processes with the ISO standards and, with the help of our Field Quality Contacts, you are in charge of developing the quality assurance procedures, comprising risk analysis and post-marketing vigilance.
You assess the consequences of technical/organisational modifications in terms of quality (organization, documentation, validation, training, premises, investments, suppliers ...) and you take the necessary actions.
You lead Quality awareness trainings to ensure information dissemination in the company and you support your team of Field Quality Contacts.
You elaborate programs for internal and external audits.
You monitor regulatory watch concerning the evolution of systems/quality tools and the regulations relating to medical devices (IVD & MD).
You are in charge of customer/supplier complaints, internal deficiencies as well as the settlement of non-conformities.
You participate in registration process for new products with the competent authorities, in particular by deposition and follow-up of the technical files.
You are the contact person for the communication with the competent authorities concerning the vigilance procedures.
You check the conformity of the distribution contracts with the vigilance regulations.
You are in charge of production of IVD kits.
Have a master’s degree or a PhD in science.
Are bilingual French or Dutch + English and you have a good knowledge of the other national language (Dutch or French).
Have a good knowledge of office tools (Windows, Excel, Word, and Outlook).
Show good communication skills.
Can anticipate and manage quality problems and needs at short, medium and long term. You will assess any request for changes in a pragmatic & company oriented way.
Are capable of developing and co-ordinating projects and/or quality assurance programs.
Have a good knowledge of the applicable regulations and norms: ISO 9001, ISO 13485, ISO 17025, IVDR, MDR & MEDDEV guidelines.
What we offer
The opportunity to join a dynamic SME that applies a long-term vision and enjoys an excellent reputation.
Autonomy in an innovative environment where a sense of responsibility and initiative are self-evident