Quality Engineer Ophthalmology
Location: NetherlandsSIRE® 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 Friesland Netherlands.
• You will be on track with the latest developments and changes of QA within the Medical Devices sector
• 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
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Minimal 3-5 years of experience within QA in the Medical Devices
• Excellent knowledge of quality standards such as ISO 13485, 21CFR820, GMP, ISO14971
• Knowledge of procedures such as validation and equipment
• Extensive knowledge of EU and US Medical Devices regulations
• Excellent leadership and organisational skills
• Fluency in English and Dutch
• Strong communicator and 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.
The Company
This organisation recently became a medical device subsidiary from an international pharmaceutical market leader. They are specialized in ophthalmology, they produce contact lenses and related products. As their organisation is expanding, there are looking for a qualified team leader.Role Description
In your role as quality engineer, you will assure that all procedures are compliant and that regulation and legal documentation are completed. 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. In addition, you are the key contact person when there are any questions or particular issues about quality topics for both internal and external stakeholders. For example, when it concerns internal and external audits. Finally, you will be involved with risk assessment, validation management, and CAPA management.Responsibilities
Your priority lies in overviewing and improving the Quality Management System. In collaboration with your team, you will bring new ideas to the quality system. Further responsibilities are:• You will be on track with the latest developments and changes of QA within the Medical Devices sector
• 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
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
Requirements
• Bachelor or Master in Life Sciences• Minimal 3-5 years of experience within QA in the Medical Devices
• Excellent knowledge of quality standards such as ISO 13485, 21CFR820, GMP, ISO14971
• Knowledge of procedures such as validation and equipment
• Extensive knowledge of EU and US Medical Devices regulations
• Excellent leadership and organisational skills
• Fluency in English and Dutch
• Strong communicator and 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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