Senior Validation Engineer
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Medical Devices organization, based in Zuid-Holland Netherlands.
A Global leading supplier in medical products is looking for a Senior Quality Engineer to support the team. They are globally producing and supplier of Innovative Medical Products in aesthetic markets around the world.
ROLE DESCRIPTION
Your objective will be to ensure compliance of the Quality Management systems as defined in the regulations and Company policies. As the new validation engineer you will optimize systems and processes that are aligned with the strategy of the company and ensuring continuous quality improvement.
RESPONSIBILITIES
As being responsible for the QMS you will support, consult, train and lead quality improvement projects throughout the whole process of the company products. This includes manufacturing, product design and development. Other responsibilities would be:
• Use statistics and process techniques to analyze and assess the quality and sampling plans of the products. Resulting in investigations for opportunities to improve.
• Responsible for pFMEA documentations and meetings including leading them
• Validation documentation
• CAPA investigations and plans
• Internal Audits what you will conduct and at times will lead
• Provide end user support and provide software validation
REQUIREMENTS
• A minimum of a University/Bachelor degree in engineering or science
• Basic statistical analysis experience
• At least 5 years relevant experience of which a minimum of 3 years is within the Pharmaceutical/Medical Device environment
• Experience and knowledge of software validation and statistics
• Preferably knowledge of computer systems and Crystal Reports Programming
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.
