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Quality Assurance
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1801204 Requisition #
 
 
 
 
Function

As our Quality Manager you have local quality management responsibility for the Healthcare products in Belgium.

 

 

Key Responsibilities

  • Maintain the Quality Management system for the Healthcare division and ensure compliance to the medical device quality standards (ISO13485, FDA CFR Part 820, Canada Health, MDD Europe, …)
  • Coordinate and manage product related quality aspects for software intensive HC products
    • Coordinate and provide pro-active collaboration, advice and decision making in the project/product development milestones within the R&D NPI process
    • Responsible to withdraw non-conforming products and stop deliveries/shipments
    • Coordinate and steer monthly product quality meetings on released products with R&D, service & product management
    • Coordinate and steer the Corrective Action and Preventive Action (CAPA) process which handles all recurring quality complaints from the field
    • Perform data analysis based on the trend data (recurring quality complaints)
  • Prepare and execute yearly management review meeting
  • Execute and follow-up internal audits (in preparation of external audits)
  • Coordinate and organize certification audits, customer audits or other inspections
  • Drive process adherence, uniformity & continuous improvement thinking across the healthcare division

 

We are looking for a new colleague who...

  • Has a master’s degree in a technical field or an equivalent combination of experience and education
  • Has proven experience in quality management (QMS) for medical devices with a minimum of 5 years
  • Has knowledge of software development processes for medical devices
  • Being a qualified auditor for ISO 13485 is a nice asset
  • Knows about active Medical Device QMS requirements for (MDD, FDA CFR part 820, Canada Health, …)
  • Has a good understanding of  risk management principles for medical devices and medical device regulatory requirements
  • Has excellent verbal and written communication skills in both Dutch and English
  • Has a demonstrated ability to steer, guide and motivate others to get things done.
  • Is a problem solver with good analytical skills to identify trends & draw conclusions from different data sets.
  • Is willing to perform limited travel per year (to Barco offices or customers)

Our offer 

  • An interesting, challenging job with lots of autonomy
  • A high-tech environment in our new headquarters               
  • Continuous training & development opportunities through our very own Barco University
  • Barco was awarded the Top Employer label 2016 for its excellent working conditions.

 

 

 

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