QA Engineer Commercial Operations
Biocartis
Mechelen, BE
5 dagen geleden

The QA Engineer Commercial Operations is responsible to support Biocartis’ 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 before and after initial release.

The QA Engineer Commercial Operations reports to the QA Manager Commercial Operations.

Accountabilities

  • Complaint Coordinator tasks;
  • 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;
  • Coordinate and follow up on investigations from External Manufacturing site Plexus;
  • 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 before and 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 processes and procedures related to Biocartis’ customer facing processes;
  • Participate in audits performed by external parties.
  • Profile requirements

  • 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 an 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;
  • Customer focused;
  • 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;
  • Excellent communicator, verbally and in writing;
  • Able to work in team and influence others;
  • Languages : Advanced knowledge, orally and in writing, of English;
  • PC skills : Experienced with MS Office (i.e. Word, Excel & PowerPoint).
  • Our offering

    We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry.

    You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary : we value your input.

    Of course we offer you an appropriate compensation package.

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