QA Medical Devices
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
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders
• Execution of root cause analyses, risk management and corrective actions
• Minimal 2 years of experience in an strictly regulated environment in a similar operational role
• Knowledge of ISO 13485 or ISO 9001
• Fluency in English and Dutch business level understanding
• Eye for detail and organizational skills
• Excellent creative thinking and a problem solving mindset
• 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 Ewout de Jong.
The Company
This organisation is developing products for the medical device 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 Quality Control for incoming products for the EMEA region. On a daily basis you are supporting the QA team on inspections, writing reports and execute tests for the materials. You will have an important role to ensure that their devices are compliant on the operational level. In addition, you have an important role for the execution of corrective actions, root cause analyses and product holds. You will become part of a dedicated and passionate QA team where you receive plenty of opportunities for personal and professional development. You will report directly to the associate manager and you will collaborate closely with your team members on both an operational and strategic level.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
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders
• Execution of root cause analyses, risk management and corrective actions
Requirements
• Bachelor in Life Sciences• Minimal 2 years of experience in an strictly regulated environment in a similar operational role
• Knowledge of ISO 13485 or ISO 9001
• Fluency in English and Dutch business level understanding
• Eye for detail and organizational skills
• Excellent creative thinking and a problem solving mindset
• 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 Ewout de Jong.
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