Quality Engineer Complaints

Mechelen / 2016018
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Full time
Experience Required

You have at least 5 years of relevant experience in an IVD – Medical Diagnostics manufacturing environment;

Profound understanding of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, GMP, …);

Education

Bachelor or Master degree in engineering or life sciences (biomedical, chemical, pharma…);

Functional Area
Quality
Travel Percentage
0-5

Purpose of the position 

The Quality Engineer Complaints will coordinate the follow-up of complaints, in close collaboration with all departments involved (primarily coordinating with the Customer Service, Sales, System Engineering, Supply chain and Manufacturing Departments).   The Quality Engineer will report to the QMS Manager.

 

Tasks/outcome domains

The function holder will be responsible to:

  • Proactively manage complaints to assure a prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to management;
  • 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;
  • Develop new and improve existing processes and procedures related to complaints;
  • 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;
  • Present KPI data on monthly management meetings;
  • 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 5 years of relevant experience in an IVD – Medical Diagnostics manufacturing environment;
  • Profound understanding of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, GMP, …);
  • Profound experience in participating in deviation investigations, determining root cause, and developing corrective action plans;
  • 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. 


Interested? 

Please apply by e-mail (motivational letter and CV in English) to HR@biocartis.com using the job ID 2016018 as a reference. 

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