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QA Engineer Commercial Operations Mechelen Belgium,  

Biocartis (company)

Posted on : 11 June 2017

Project Description

Purpose of the position  
  • The QA Engineer Commercial Operations is responsible to support our company  customer facing processes from a quality perspective. 
  • This includes coordinating the follow-up of Customer Complaints, in close collaboration with all departments involved and maintaining a quality oversight on commercial instrument and console activities after initial release. 
  • The QA Engineer Commercial Operations is coached by the QA Manager Commercial Operations. 


Tasks/outcome domains 
The function holder will be responsible to: 
  • Review all registered complaints for completeness; 
  • Drive investigations in collaboration with other departments, related to complaints,  to obtain thorough root cause analyses and adequate definition of an action plan; 
  • Coordinate corrective and/or preventive actions related to complaints, and follow-up of their timely implementation and effectiveness; 
  • Proactively manage complaints and escalating concerns as required to management; 
  • Organize and provide training of personnel in relation to management of complaints; 
  • Identify complaint trends and call for action from the organization when action is needed to improve trends that require improvement; 
  • Keep the quality oversight on commercial instrument and console manufacturing activities after initial release (review of batch records and handling of process non conformities) and quality oversight on processes as outgoing shipments, installation and servicing; 
  • Participate in continuous improvement of existing procedures related to our company customer facing processes; 
  • Participate in audits performed by external parties.   

Profile and competencies  
  • Bachelor or Master degree in engineering or life sciences (biomedical, chemical, pharma &); 
  • You have at least 1 year of relevant experience in a quality function within the healthcare industry; 
  • Experience in IVD  Medical Diagnostics manufacturing environment is a plus; 
  • Experience in participating in deviation investigations, determining root cause, and developing corrective action plans; 
  • Experience with Customer Complaints is a plus. 
  • Understanding of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, GMP) is a plus; 
  • You are customer focused; 
  • You work very accurately and have an eye for detail; 
  • Excellent organization and prioritization skills, and able to adapt to changing priorities; 
  • Good analytical and conceptual thinking skills with the ability to solve key problems; 
  •  You are an excellent communicator, verbally and in writing,  with good decision making skills; 
  • Able to comprehend processes in short time frames; 
  • Able to work in team and influence others; 
  • Advanced knowledge, orally and in writing, of Dutch and English; 
  • Experienced with MS Office (i.e. Word, Excel & PowerPoint).  

Our offering  
  • We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. 
  • You can be part of a very dynamic, young and growing team in a highly innovative environment. 
  • You will have freedom to shape your work and shape your job.
  •  Your input is highly appreciated. Of course we offer you a fitting compensation package.  


2800 Mechelen Belgium

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