EXPERT ADVISOR - (CLINICAL) LABORATORY QUALITY MANAGEMENT SYSTEMS (M/F/D)
FULL TIME

Platomics is dedicated to bringing the power of personalized medicine into everyday healthcare by making genetic testing easy and affordable. For this purpose, our team applies the most advanced computing technologies to enable big data processing and analysis in healthcare. We are a vibrant team, with backgrounds in bioinformatics, genetics and software development.
 

As a Laboratory Quality Management Advisor you have the following responsibilities:

  • Contribute to our development activities on the digitalization of laboratory processes

  • Support our laboratory partners and customers in setting up compliant quality management systems and lab-developed tests

  • Consult on maintenance, improvement and assessment of Laboratory Quality Management System 

  • Support in risk management according to ISO 22367, ISO 14971

  • Support in the creation of digital QMS processes and documentation

  • Support related departments, e.g. with internal trainings

  • Contribute to our digital documentation (product and process related)
     

Required Qualifications:

  • Technical or scientific degree, e.g. biomedical engineering, informatics

  • Experienced in (clinical) Laboratory quality management systems

  • Knowledge on ISO 15189, ISO/IEC 17025

  • Experience in topics such as uncertainty estimation, method validation, proficiency testing, calibration and modern interpretation of traceability subject, as well as audit methods and tools

  • Experienced in setting up (clinical) In-house manufactured tests (lab-developed tests, LDT)

  • Sense of responsibility, reliability, high carefulness and accuracy in the way of working

  • Taking actions purposefully and structured

  • Very good German and English language, spoken and written

  • Self-organizing, meeting deadlines

  • Team player
     

Preferred Qualifications:

  • Work experience in accredited or to-be accredited laboratories

  • Knowledge on GLP, CLIA

  • Knowledge on Genetic Testing

  • European medical device regulations, in particular on the In Vitro Diagnostic Device Regulation IVDR
     

We offer:

  • Interesting topics in a rapidly growing market

  • Challenging and varied tasks

  • Flexible work schedule 
     

You’ll earn an appropriate salary starting at EUR 44.660 gross per year (IT-KV). Willingness for over-payment is given for candidates with proper experience and/or qualifications.

The Platomics office is very conveniently located close to Praterstern, easily reachable via U1, U2, S-Bahn and ÖBB. We offer flexible working arrangements.

Apply via: careers@platomics.com or call +43 660 710 93 70