QA Manager EMEA region

Location: Belgium

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 Anvers Belgium.

The Company

This organisation is developing devices that are concentrated on the cardiology sector. Their aim is to help clients by the creation of innovative and highly technological devices. They are operating on an international level varying from the United States, Latin America and Asia.

Role Description

In your position as Quality Assurance manager for the Logistics site. Your main focus is on the improvement and the maintenance of the Quality Management System. You will overview and control all procedures and required documentation for the compliancy of the QMS. You are responsible for Quality of the European, Middle-Eastern and Asian logistics site. You are a key contact person when it comes to issues and questions in relation the QMS for both internal and external stakeholders. You will be involved in the development of training and of strategies and activities regarding quality. Furthermore, you will be closely collaborating with other logistic centres to ensure global alignment.

Responsibilities

As mentioned previously, you will overview and control all activities concentrated on the improvement and the maintenance of the Quality Management System. Furthermore, you are responsible for:
• Guidance and support to team members and various
stakeholders across the organisation
• Ensuring that nonconformities are identified, performing GAP
analyses, executing CAPA’s and implementing strategies of
improvement
• Taking responsibility during internal and external audits
• Defining Key Performance Indicators for the EMEA Quality
Logistic site
• Checking test equipment for sufficient calibration and verification
which should be suitable for specific verification and testing
activities
• Development of training activities and execution
• Key contact person for all issues and questions related to the
QMS

Requirements

• Bachelor in Life Sciences
• Minimal 5 years of experience within the Medical Device
industry in a Regulatory role
• Minimal 3 years of experience within a Logistics company
• Excellent knowledge of ISO 13485 and ISO 9001
• Knowledge of the Medical Device Directive and Medical
Device Regulation, and the FDA Regulations
• Experience with the improvement and maintenance of
Quality
Management Systems
• Fluency in English
• Magnificent organisational and analytical skills
• Excellent team player

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.