Apply now »
Location: 

Kortrijk, BE

Date:  Jul 27, 2022
Job ID:  5641

Quality Manager Healthcare

Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). Our solutions make a visible impact, allowing people to enjoy compelling entertainment experiences; to foster knowledge sharing and smart decision-making in organizations and to help hospitals provide their patients with the best possible healthcare. Headquartered in Kortrijk (Belgium), Barco realized sales of 804 million euro in 2021 and has a global team of 3,000+ employees, whose passion for technology is captured in +500 granted patents.

Function 

 

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

 

 

Key Responsibilities 

  

  • You 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, …) 
  • You coordinate and manage product related quality aspects for software intensive healthcare products
  • You coordinate and provide pro-active collaboration, advice and decision making in the project/product development milestones within the R&D NPI ('new product introduction') process 
  • You are responsible to withdraw non-conforming products and stop deliveries/shipments 
  • You coordinate and steer monthly product quality meetings on released products with R&D, service & product management 
  • You coordinate and steer the Corrective Action and Preventive Action (CAPA) process which handles all recurring quality complaints from the field 
  • You perform data analysis based on the trend data (recurring quality complaints) 
  • You prepare and execute yearly management review meeting 
  • You execute and follow-up internal audits (in preparation of external audits) 
  • You coordinate and organize certification audits, customer audits or other inspections 
  • You 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)

 

 

Apply now »