QA Engineer Sales

QA ENGINEER SALES

• 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 will be highly appreciated.
• We also offer you a fitting compensation package.

The company is an innovative molecular diagnostics company committed to revolutionize molecular testing. They 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.

The company’s proprietary molecular diagnostics 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.

The QA Engineer Sales is responsible to support the companies’ 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 Sales reports to the QA Manager Operations & Sales. The role includes, but is not limited to, the following 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;
• 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 companies’ customer facing processes;
• Participate in audits performed by external parties.

Education:

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

Experience:

• 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.

Technical/Theoretical knowledge, skills and expertise

• 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.

Legislation and regulation

• ISO13485:2016
• FDA 21 CFR 820
• MDSAP
• GDP
• GMP
• IVDR

Languages

• Advanced knowledge, orally and in writing, of English.