Quality & Regulatory Project Leader
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 Noord-Brabant Netherlands.
• Providing advice and support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• 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
• Creating awareness of importance RA and QA within the corporate organisation by using internal resources
• Controlling and assessment of promotion materials with relevant documentation and product specifications
• Taking the lead in decision-making and development of trainings
• Minimal 5 years of experience with QA on a production site within the Medical devices industry
• Minimal 3 years of experience in an strictly regulated environment
• Proven experience with the maintenance and improvement of QMS
• Excellent knowledge of American and European legislation and regulations
• Fluency in English, and good understanding of the Dutch language
• Critical scope and excellent analytical skills
• Understanding and broad knowledge of Lean-six sigma procedures
• Experience in project management
• Ability to train team members
• 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.
The Company
They are a professional Healthcare and Medical Devices and operates at an international level. They are one of the leaders in technological developments and innovation.Role Description
QA and RA are set at a high standard. On a daily basis you are involved with regulations, compliancy and you are overviewing developments and required changes within the QMS. In your role as Quality and Regulatory project manager, you are in charge of the QMS including all-related activities. You will overview, control and improve this system. You are responsible for tracking and being fully aware of all changes within the regulatory domain for Europe and the US. This project lasts for a year with a possibility for extension to one additional year.Responsibilities
Your daily responsibility contains the overview and maintenance of the QMS for this particular site including the relevant documentation. Furthermore, you are responsible for:• Providing advice and support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• 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
• Creating awareness of importance RA and QA within the corporate organisation by using internal resources
• Controlling and assessment of promotion materials with relevant documentation and product specifications
• Taking the lead in decision-making and development of trainings
Requirements
• Bachelor in Life Sciences• Minimal 5 years of experience with QA on a production site within the Medical devices industry
• Minimal 3 years of experience in an strictly regulated environment
• Proven experience with the maintenance and improvement of QMS
• Excellent knowledge of American and European legislation and regulations
• Fluency in English, and good understanding of the Dutch language
• Critical scope and excellent analytical skills
• Understanding and broad knowledge of Lean-six sigma procedures
• Experience in project management
• Ability to train team members
• 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.
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