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.