Medical Device Validation Engineer
SIRE Life Sciences®
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SIRE® 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 Limburg Belgium.
The CompanyThis international market leader within the Medical Devices industry is continuously growing. They are one of the leaders in technological developments and innovation. They are active within a broad range of industries, and focus on technology and innovation.
Role DescriptionIn your role as Validation engineer you will be responsible for the procedures and strategies that are dedicated to provide data within the quality system. You will take the lead in various projects related to computer system validation. You will support the department with validation management involving quality procedures and certain tools that arrive from or need to be implemented in the system. Furthermore, you are involved with internal and external audits where you are the contact person during the process. You will show your expertise by guiding the department in developing software solutions and designs. Finally, you are involved with risk management and change control where you will indicate changes and points of improvement for the QMS. This project is estimated for a period of 1 year with a possibility to extension.
ResponsibilitiesYou will take the lead on site for the computer system validation related projects. You will work closely with various departments from different sites. Furthermore, you are involved with:
• Daily support in maintenance and development of all validated systems
• Monitoring the improvement and development of the computer system validation to MT
• Execution of risk management activities varying from reviews, to performing mitigation activities
• Ensuring compliancy of the system regarding European and US quality standards such as FDA regulations and GAMP 5 principles
• Planning and organizing data, plans and collecting reviews of documentation required for the software development lifecycle process
• Providing expertise in the development of Software structures
• Guiding and giving insights into software validation, compliancy and developing recommendations
Requirements• Bachelor or Master in engineering
• Minimal of 7 years of experience in an IT function
• Several years of experience within a QA role in the Medical Devices industry
• Experience in working with (software) quality standards such as 21 CFR, ISO 13485, GAMP 5 and preferably Canadian Regulations and Asian standards.
• Providing evidence for the ability for validation and software implementation from multiple projects
• Excellent communicator and team player
• Strong analytical and organizational skills
• Eye for detail
• Fluent in English (written and spoken) and preferably German
• Willing to travel about 50%
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.