QUALITY ASSURANCE COORDINATOR (M/F)

Analis SA (www.analis.be) is a Belgian company located in Suarlée (Namur) and in Gent. We are engaged in sales, scientific and technological support, as well as maintenance of laboratory equipment. Besides these activities, we are also a manufacturer of in vitro diagnostic kits. Thanks to our exclusive partnership with major brands, we are positioned among important market players in Belgium for more than 90 years already. Our customers range from medical, research & industrial laboratories to hospitals. Each day, we can rely on a staff of 130 people who commit themselves to the development of our business. We realize a turnover of nearly 30 million euros.

Our job offering…

  • As a member of the 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 and you take the necessary actions.
  • By a strong field presence and close collaboration with process leaders, you ensure quality awareness in the company.
  • You support your team of Field Quality Contacts.
  • You train all collaborators in QA affairs.
  • 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 all aspects linked to vigilance: communication with authorities, check conformity of new distribution contracts.

As a candidate, you …

  • Have a master’s degree and/or a good quality background.
  • Show very good communication skills.
  • Are bilingual French or Dutch + English and you have some knowledge of the other national language (Dutch or French).
  • Have a good knowledge of office tools (Windows, Excel, Word, and Outlook).
  • 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 (IVDR, MDR & MEDDEV guidelines) and ISO 17025.

What do we offer?

  • The opportunity to join a dynamic SME that applies a long-term vision and enjoys an excellent reputation.
  • High-level trainings
  • Autonomy in an innovative environment where a sense of responsibility and initiative are self-evident.