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Temporary Quality System Specialist

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Temporary Quality System Specialist

Location: Netherlands

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 Noord-Holland Netherlands.

This client is involved with the development of highly innovative rehabilitation technologies. Their innovation lies in the use of virtual reality. They are a global market leader in the area of sport, rehab, intelligent medication and wholesalers spread across Asia, the United States and the Netherlands.

ROLE DESCRIPTION

In your role as a Quality Assurance expert, you will provide support to the QA team regarding the Quality Assurance System and all related activities. You will help to improve the QMS and you will have a major role when it comes down to various procedures such as the development of strategies for compliancy, participation in both internal and external audits, and changes for ISO qualifications. You will be contacted whenever there are any particular issues with the ISO standards, the Quality Management System, and related documentation or legislation. The duration of this project is estimated for 8 months and there is a possibility that this project will be extended with 4 additional months.

RESPONSIBILITIES

• Updating and maintaining the QMS and related procedures
• Supporting and guiding audits from the beginning to the end
• Acting up on notifications retrieved from audits such as CAPA’s and risk management procedures
• Implementation, monitoring and maintenance of FDA Quality standards, ISO and Medical Device Regulations
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Providing advice and support to management in set up of QA/RA processes
• Management and control of QMS documentation and reviewing these documents
• Execution and guidance during internal and external audits, and being the contact person for any occurring issues

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 4 years of experience within the Medical Devices industry
• Minimal 2 years of experience in a Quality Assurance role
• Experienced in complaint handling
• Excellent knowledge of ISO 13485 and FDA standards
• Team player, yet strong individual
• Excellent analytical skills
• Knowledge of European and International Regulatory Affairs
• Fluency in English and Dutch

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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SIRE Life Sciences®

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