Quality Assurance Specialist
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 Noord-Holland Netherlands.
The CompanyThis innovative and high-technology driven organisation is a Medical Device start-up. They have made incredible progress over the past few years and are therefore looking to extend their team. At this stage they ae looking for a passionate and dedicated QA professional.
Role DescriptionYou will become part of an informal and dynamic business setting in which quality is set at a high standard. You will receive various responsibilities that are directed to maintain and improve the Quality Management System according the ISO 13485 standard and related activities. You will be involved with the preparation and execution of internal and external audits, the creation of awareness among other colleagues and customers, and interaction with different departments from a quality perspective. Finally, you will gain insights into improvements and developments for the QA department.
ResponsibilitiesOn a daily basis you are involved with maintenance and improvement of the Quality Management System. 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 standards
• Providing support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s and performing risk management
• 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 or Master, preferably in the Life Sciences
• Minimal 2-3 years of experience in a QA position
• Proven experience with the maintenance and improvement of a QMS
• Experience with audits and inspections of notified bodies and other authorities
• Excellent knowledge of American and European legislation and regulations
• Fluent in English and preferably Dutch
• Critical scope and excellent analytical skills
• Result- oriented and a thorough quality mind-set
• 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 Juliette van Kraaij.