QA Engineer Commercial Operations

21/04/20

Location

Generaal de Wittelaan 11B Mechelen Belgium

Function type

Quality

Vacancy

About Biocartis

Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.
Biocartis’ proprietary molecular diagnostics (MDx) IdyllaTM platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring.
Biocartis employs over 450 people and is headquartered in Mechelen, Belgium.

QA Engineer Commercial Operations

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 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 via HR@biocartis.com

Job application