SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Medical Devices organisation, based in Vlaams-Brabant Belgium.

The Company

They are an international company that have a focus on different markets. The client provides equipement and services for laboratories.

Role Description

QA 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