QA Specialist Medical Devices
SIRE Life Sciences®
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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 Oost-Vlaanderen Belgium.
The CompanyGlobally operating company is active in, among others, Medical Devices. Our client attracts ambitious international talent and offers enough opportunities to grow within the organization.
Role DescriptionIn your role as Quality Specialist you will be responsible for the procedures and strategies that are dedicated to provide data within the quality system. You will take the lead in various projects related to computer system validation. You will support the department with your knowledge and experience of product development and quality management. Furthermore, you are involved with risk management and change control procedures where you will indicate changes and points of improvement for the QMS. This project is set till the end of the year and will be extended in the new year.
ResponsibilitiesYour main focus is to support the department of new products that need to be aligned with the ISO 13485 and related regulations. In addition, on a daily basis you are involved with:
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Gain insight into possible points of improvements for the QMS according to ISO 13485 and IEC62304 standards
• Providing support to management in set up of QA/RA processes
• Execution of risk management and related procedures
• Management and control of QMS documentation and reviewing these documents
• You will be on track with the latest developments and changes of QA within the Medical Devices sector, involving regulations & legislation such as the MDR and FDA
Requirements• Bachelor in Life Sciences
• Minimal 2 years of experience with QA within the Medical devices
• Proven experience with the maintenance and improvement of QMS according ISO 13485 and IEC standards such as IEC 62304
• Excellent knowledge of American and European legislation and regulations
• Fluent Dutch language and business proficiency English
• Critical scope and excellent analytical skills
• Team player, yet individual operator
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.