QA/RA Specialist
Location: BelgiumSIRE® 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 Bruxelles-Capitale Belgium.
• Develop and maintain the Quality Management System to fulfil the ISO 13485 requirements and Company requirements
• Report directly to the QA/RA Central Region Manager.
• Work in collaboration with local management in Belgium and QA/RA EMEA and act as back-up for QA/RA Specialist in Netherlands
• Further development and maintenance of the existing Quality Management System in Sales organization.
• Deploy EMEA/Corporate processes and procedures within the organization
• Write appropriate procedures and maintain the Quality Management System document control
• Support and perform internal audits
• Handle Quality issues and complaints, and actively support product surveillance
• Manage instructed recalls and Field Actions, in collaboration with Management of Operations
• Establish good relationships with the local Competent authorities
• Provide required monthly reports to EMEA Management
• Participation at local association meetings.
• Occasional involvement in special projects and special duties.
• Certificated education in quality management and 4 to 6 years verifiable experience in quality assurance. Must be familiar with standard business platforms.
• Languages Dutch/French/English
• Good knowledge of Quality Management system requirements, ideally in medical device industry in Europe.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
The Company
They are a world leading Medical Device manufacturer that has been a example in the industry for many decades. Their innovative environment gives not only opportunities to develop in personal and professional expertise, but will give as well the opportunity to work with life changing products and provide a service to patients that are in need of these services. The company is now looking for a QA/RA specialist to take responsibility in their site in Brussels.Role Description
• Ensure product Quality and Regulatory compliance in country distribution subsidiary• Develop and maintain the Quality Management System to fulfil the ISO 13485 requirements and Company requirements
• Report directly to the QA/RA Central Region Manager.
• Work in collaboration with local management in Belgium and QA/RA EMEA and act as back-up for QA/RA Specialist in Netherlands
Responsibilities
The Main tasks and responsibilities will include:• Further development and maintenance of the existing Quality Management System in Sales organization.
• Deploy EMEA/Corporate processes and procedures within the organization
• Write appropriate procedures and maintain the Quality Management System document control
• Support and perform internal audits
• Handle Quality issues and complaints, and actively support product surveillance
• Manage instructed recalls and Field Actions, in collaboration with Management of Operations
• Establish good relationships with the local Competent authorities
• Provide required monthly reports to EMEA Management
• Participation at local association meetings.
• Occasional involvement in special projects and special duties.
Requirements
• B.S. degree in engineering, science, management or equivalent experience.• Certificated education in quality management and 4 to 6 years verifiable experience in quality assurance. Must be familiar with standard business platforms.
• Languages Dutch/French/English
• Good knowledge of Quality Management system requirements, ideally in medical device industry in Europe.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
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