QA Specialist
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.
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Collecting and creating reports of outcomes from investigations/audits especially for CAPA’s
• Supporting audits for the EMEA region
• Management and control of QMS documentation and reviewing these documents
• Providing input and support to management in set up of QA/RA processes, activities and procedures
• Interaction and communication with both internal and external stakeholders
• Minimal2 years of experience in an strictly regulated environment
• Knowledge of ISO 13485 or ISO 9001
• Proven experience with the maintenance and improvement of QMS
• Fluency in English and Dutch business level understanding
• Excellent analytical skills and organizational capabilities
• Evidence of experience in working on a project basis
• Excellent creative thinking and a problem solving mindset
• Team player
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met 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
Quality is set at a high standard. You will focus on the QA processes and procedures for the EMEA region. On a daily basis you are supporting the operations department from a QA perspective, in order to ensure that their devices are compliant with both internal and external regulations and quality standards. In addition, you will make sure all required documentation is collected and related tasks are executed. You will become part of a dedicated and passionate QA team where you receive plenty of opportunities for personal and professional development.Responsibilities
As Quality Process Specialist your main responsibility is to be involved with operational and back office QA activities. Furthermore, you are involved with:• Identifying points of development for the QMS and making adjustments in relevant documentation
• Collecting and creating reports of outcomes from investigations/audits especially for CAPA’s
• Supporting audits for the EMEA region
• Management and control of QMS documentation and reviewing these documents
• Providing input and support to management in set up of QA/RA processes, activities and procedures
• Interaction and communication with both internal and external stakeholders
Requirements
• Bachelor in Life Sciences• Minimal2 years of experience in an strictly regulated environment
• Knowledge of ISO 13485 or ISO 9001
• Proven experience with the maintenance and improvement of QMS
• Fluency in English and Dutch business level understanding
• Excellent analytical skills and organizational capabilities
• Evidence of experience in working on a project basis
• Excellent creative thinking and a problem solving mindset
• Team player
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Juliette van Kraaij
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