Your responsibilities:
* Management of the QC department, taking into account the relevant regulatory requirements
* Leading a team of 10 employees
* Responsibility for the release of intermediate and end products of our product lines, ELISA, LINE and
PCR in accordance with EN ISO 13485 for in vitro diagnostics
* Ensuring the product quality of raw materials (incoming goods inspection)
* Decisions on Out-of-Specification (OOS), as well as tracking resulting corrective and preventive
measures
* Collection of stability data of the products to determine the shelf life
* Monitoring product quality by participating in external proficiency testing, including Post Market
Surveillance (PMS)
* Processing of customer inquiries and complaints in collaboration with Customer Service
* Creation and revision of SOP's and procedures in the document management system
* Continuous optimization of processes with regard to quality, costs and adherence to deadlines using
relevant key figures (KPIs)
* Validation of QC processes and qualification of equipment
* Training and further education of QC employees
Your profile:
* Completed natural science or medical university education
* Several years of professional experience in quality control of in vitro diagnostic or medical products, QC management experience is desirable
* Very good knowledge of the regulatory requirements in Europe (IVD Directive 98/79/EC, DIN EN ISO 13485, as well as IVDR requirements)
* Experience in the field of infectious disease diagnostics (ELISA, Line Immuno Assay, CLIA, PCR)
* Careful and structured approach
* Experience in team leadership, communication skills and motivation
* Very good skills in analysis and summarization of technical data
* Understanding of laboratory processes, as well as experience in conducting root cause analyses
* Reliable handling of computer applications (MS Office)
* excellent German and English language skills
All passionate Quality control leaders are welcome to apply!
