Quality Analyst

25/11/21

Location

Gaston Geenslaan 1, 3001 Leuven, Belgium

Function type

Quality

Vacancy

About miDIAGNOSTICS

miDiagnostics is using silicon chip technology that will bring miniaturized, lab-quality tests with built-in device connectivity and rapid results direct to the patient and clinician. Combining a nano-fluidic processor on a chip and a compact reader, miDiagnostics can measure virtually any biomarker from an easily accessed sample such as a single drop of blood. The Company is developing an extensive portfolio of tests for screening, diagnosis and monitoring of a wide range of health conditions, including infectious diseases. Spun out of the world-leading R&D and innovation hub in nanoelectronics and digital technologies, imec, and a research collaboration with Johns Hopkins University, the leading US research and medical centre, miDiagnostics’ goal is to enable fast, comprehensive and cost-effective health analysis, regardless of location. Based in Leuven, Belgium, miDiagnostics is a privately-held company created in 2015.

The Job

With the launch of rapid COVID 19 PCR test, we are currently seeking a Quality Analyst to join our Quality team.

As our Quality Analyst, you will be responsible, in close collaboration with our Assay Development team, for the creation, development, validation and execution of liquid and powder test methods and means of analysis, including reagent components, in process production and final product release PCR testing.

Besides, you will:

  • Create, validate and execute identity tests, qualitative and quantitative methods included.

  • Execute following Assay test types: content uniformity, precision, reproducibility, repeatability, range, Limit Of Detection (LOD), Limit Of Blank (LOB), Limit Of Quantification (LOQ), carry-over.

  • Guarantee a good record keeping and diligent reporting.

  • Create and follow Quality Control instructions and document all findings.

  • Prioritise and escalate issues in a timely manner.

  • Report your analyses so that actions can be taken if necessary.

  • Help in maintaining and further improving Quality Control instructions to keep up with the changing environment of a start-up company.

  • Partner and support other colleagues in various teams, particularly Operations and Development.

Your initiatives help to achieve our quality objectives on product and company level.

Your profile and competencies

  • Bachelor/Master degree in a scientific discipline in a chemistry related field: chemistry or biochemistry, or specialist quality or lab degree.

  • A minimum of 2 years previous experience in an analytical quality role in a highly regulated industry, such as medical device (ISO 13485), IVD or pharmaceutical setting.

  • Good analytical and accurate laboratory skills

  • Familiar with analytical equipment (pros and cons), equipment calibration and measurement systems.

  • Good numeracy skills.

  • Work in a structured and methodological way is a must.

  • Complete tasks efficiently and systematically.

  • High attention to detail and well organised

  • Work well in a team but equally can operate autonomously with personal accountability for objectives.

  • Reliable and communicative colleague.

  • Ethical attitude and high integrity.

  • You feel comfortable in a start-up environment. You have a flexible attitude and eagerness to learn.

  • You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues.

  • Good level of English. Knowledge of Dutch is an asset

  • Comfortable with Microsoft Office tools – Word, Excel, etc

  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed.

The offer

  • A job in a fast-growing and ambitious start-up in the medical diagnostics industry.

  • miDiagnostics is an international-oriented company with close connections to two world-class research institutions (imec and Johns Hopkins University).

  • Opportunity to grow in a new and exciting cutting-edge field in point-of-care diagnostics.

Interested? Please apply via our career website https://jobs.midiagnostics.com/

Job application