Sterilisation QA professional

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Medical Devices organization, based in West-Vlaanderen Belgium.

This organisation is offering sterilisation services for various medical device organisations and hospitals within the Benelux. They are providing customised and highly innovative solutions for their clients. Quality is crucial for this organisation and therefore, they are looking for the right support.

ROLE DESCRIPTION

You will directly report to the QA & QC manager. You are able to give advice and exchange your knowledge with the manager, and across other teams. You are playing a major role when it comes down to sterilisation procedures, lab activities and medical device manufacturing. You will be involved in structuring processes, creating strategies and improving the Quality Management System. You will have a major role when comes to decision making and sharing your knowledge. On a daily basis you will be involved with the establishment and maintenance of relationships with internal and external relationships. This project is set for 5 months which can be extended to 8 months.

RESPONSIBILITIES

On a daily basis you gain insight into possible points of improvements for the QMS, and you will also be on track with the latest developments and changes of QA within the Medical Devices sector. Furthermore, you responsibilities involve:
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Overview and collect required documentation and legislation in relation to the product specifications
• Review and assessment of procedures involving risk and validation management at the manufacturing site
• Taking the lead in organizing internal and external audits, guiding the process from the beginning to the end
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations

REQUIREMENTS

• Master in Life Sciences
• Minimal 3 years of experience within the Medical Devices industry
• Minimal 2 years of experience within a QA role
• Additional experience of Quality Control
• Excellent knowledge of ISO 13485: 2016 standards
• Broad knowledge of European and international regulation
• Fluency in both Dutch and English
• Eye for detail and excellent analytical skills
• Proven experience in improving and developing Quality Management Systems
• Pro-active attitude
• Excellent problem-solving 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.