Quality Assurance Engineer EMEA Logistics
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 Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands.
• Ensuring that nonconformities are identified, performing GAP analyses, executing CAPA’s
and implementing strategies of improvement
• Guidance and support during internal and external audits from the beginning to the end
• Support and assist in the achievement of mutual goals for the EMA Quality Logistic site
• Development of training activities and execution
• Support for all issues and questions related to the QMS
• Minimal 5 years of experience within the Medical Device industry in a Regulatory role
• Minimal 3 years of experience within a Logistics company
• Excellent knowledge of ISO 13485 and ISO 9001
• Knowledge of the Medical Device Directive and Medical Device Regulation, and the FDA
Regulations
• Experience with the improvement and maintenance of Quality Management Systems
• Fluency in English
• Independent and excellent analytical skills
• Excellent team player
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 is developing devices that are concentrated on the cardiology sector. Their aim is to help clients by the creation of innovative and highly technological devices. They are operating on an international level varying from the United States, Latin America and Asia.Role Description
In your position as QA Engineer for the Logistics site. You will support the local site on the improvement and the maintenance of the Quality Management System. On a daily basis you are involved with collecting and reviewing all procedures and required documentation for the compliancy of the QMS. You will be part of the Quality Team that takes care of the European, Middle-Eastern and Asian logistics site. You will support and guide the team in relation to internal and external stakeholders. You will assist in the maintenance and establishment of relationships with suppliers, customers and notified bodies. Furthermore, you and your team will be closely collaborating with other logistic centres to ensure global alignment.Responsibilities
As mentioned previously, you will support all activities concentrated on the improvement and the maintenance of the Quality Management System. Furthermore, you are responsible for:• Ensuring that nonconformities are identified, performing GAP analyses, executing CAPA’s
and implementing strategies of improvement
• Guidance and support during internal and external audits from the beginning to the end
• Support and assist in the achievement of mutual goals for the EMA Quality Logistic site
• Development of training activities and execution
• Support for all issues and questions related to the QMS
Requirements
• Bachelor in Life Sciences• Minimal 5 years of experience within the Medical Device industry in a Regulatory role
• Minimal 3 years of experience within a Logistics company
• Excellent knowledge of ISO 13485 and ISO 9001
• Knowledge of the Medical Device Directive and Medical Device Regulation, and the FDA
Regulations
• Experience with the improvement and maintenance of Quality Management Systems
• Fluency in English
• Independent and excellent analytical skills
• Excellent team player
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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