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Validation Engineer Leuven Belgium,  

Materialise (company)


Posted on : 24 June 2017

Project Description

Description:
  • Our company is a dynamic Belgian high-tech worldwide company, founded in 1990, with over 1,000 employees worldwide. Our mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D Printing).
  •  Our customers are in diverse industries, such as automotive, aerospace, medical, research and academia.
  •  As a growing company, our company is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.        

Validation Engineer 
  • As a Validation Engineer you will become responsible for further improving our validation approach in the field of 3D printing metal implants. Note: initially, you will focus on the metal implant 3D printing and post-processing process. 
  • Further scope extensions are expected in the future.
  •  Your initial scope will be mainly around 2 topics: 
  • QMS compliance of Validation dossiers 
    • Integration of 2 existing validation dossiers (aMace & TruMatch) inside the QMS system: 
      • Review approach & documentation of 2 existing validation files (MasterFile, test protocols, approach, &) of aMace & TruMatch
      • Integrated used approach & documentation inside QMS SOPs
      • Based on outcome of validation dossiers, set re-validation requirements after process changes such as 3D print maintenance actions
      • This is a short-term task with high priority  
    • Prepare future validation dossiers by establishing best practices inside QMS system
      • Recommend & implement further improvements to the QMS system leading to improvements to the Validation Dossier approach and documentation hereoff
      • This is a mid-term task with high priority 
  • Validation Execution 


Note: the hereunder tasks are the core of the Validation Engineer s tasks and should become the main task after the initial QMS compliance works    
  • Take part in execution of new Validation Dossier approach by writing validation/research test protocols "TP's" (together with material/process experts) and ensure these are correctly translated into instructions for the operators/production team
  • Analyse test data (via statistical analysis in MiniTab) to confirm expected relevant links  but also unexpected links  between different test data, and write test data analyse DAT  reports
  • Execute a detailed metal implant manufacturing Process Variability Assessment, continuously updated based on lessons learnt
  • Translate Research process insights/pre-tests  which have been assessed to be relevant for the process Validation  into best practices documented inside the QMS  



Requirements 
  • A master s degree in engineering is required; a first experience in process engineering and/or validation is a plus.
  • You have an analytical engineering way of thinking and proposing solutions with a very strong reality-check mindset.
  • You are fluent (writing/verbally) in English.
  • You understand the criticality of the works you are doing for the patients and for o
  • You are accurate with a focus to delivery high quality work.
  • You are open to travel occasionally.
  • You are good in working in a team.     


Offers:
  • People are the cornerstone of our company and we treasure the talent, skills, and values of our employees very highly. 
  • We believe that maintaining the right environment and culture for employees is crucial for an organization s success. 
  • Therefore, we are devoted to building a global team of specialists in an open environment that favors personal growth. 
  • Programs have been put in place to keep our fair, direct company culture alive. 
  • Moreover, we proudly invest in personal development and offer challenging careers where employees are empowered to grow professionally as well as personally. 
  • You will liaise with different people throughout the organization on a daily basis and we guarantee that no day will be the same. 
  • Your effort and energy will be rewarded with a competitive salary and with extralegal advantages. 
  • In order to have a good work-life balance, we offer you flexible working hours.        

Locations

3001 Leuven Belgium

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