QA Engineer
SIRE
Vlaams-Brabant, Belgium
3 dagen geleden

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 Medical Devices organisation, based in Vlaams-Brabant Belgium.

The Company

This organisation is a manufacturer and developer of medical devices and supplementary products. They are operating internationally and have production sites in Asia.

They are responsible for the entire process and also import and export their diverse line of products across the world.

Role Description

In your role as Quality Assurance engineer, you will gain the responsibility to support the maintenance and improvement of the QMS which also requires broad knowledge of related documentation and legislation.

You will be a guide during internal and external audits as you will give advice and make reports during the execution. Furthermore, you are the contact person on the site when it comes down to questions and related issues with the QMS, both for internal and external stakeholders.

You will give major input for training sessions and you will exchange your knowledge on the site continuously.

Responsibilities

As Quality specialist your main responsibility is to improve and maintain the Quality Management System and involved documentation.

Furthermore, you are involved with :

  • Identifying points of development for the QMS and making adjustments in relevant documentation
  • Providing advice and support to management in set up of QA / RA processes
  • Collecting and creating reports of outcomes from audits especially for CAPA’s
  • Controlling and assessment of promotion materials with relevant documentation and product specifications
  • Management and control of QMS documentation and reviewing these documents
  • Interaction and communication with both internal and external stakeholders concerning product launch and regulations
  • Key contact person for QMS related topics and questions
  • Requirements

  • Bachelor in Life Sciences
  • Minimal 3 years of experience with QA on a production site within the Medical devices industry
  • Minimal 2 years of experience in an strictly regulated environment
  • Proven experience with the maintenance and improvement of QMS
  • Broad knowledge of European and International legislation and regulations
  • Team player with extraordinary communication skills
  • Fluency in English, and good understanding of the Dutch language
  • Critical scope and excellent analytical skills
  • 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.

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