Wissenschaftler / Design Responsible (m/w/d)
Core
Responsible for the production process of EliA Well-Fixed Phase assays, creating QC processes and specifications, and supporting product registrations.
Role type
Senior Scientist / Design Responsible (In-Vitro Diagnostics)
Builds
Automated blood analysis systems for allergy and autoimmune diseases
Domain
Life Sciences / In-Vitro Diagnostics / Immunology
Required skills
Immunological testing, Regulatory text implementation, Product registration, Product Life Cycle Management (OPLM), Risk management, Complaint handling
Preferred skills
Product audits, Interdisciplinary team collaboration
Technologies
OPLM software
Responsibilities
Responsible for the production process of EliA Well-Fixed Phase assays, Create QC processes and specifications, Support product developments and registrations, Represent site interests in external committees (e.g., CLSI), Participate in complaints, non-conformities, CAPAs, and risk management
Seniority
Senior, hands-on IC