Scientist Quality Assurance and Process Care (m/f/d)
Core
Provide scientific support for quality control and assurance of in vitro diagnostic (IVD) products for autoimmune diseases, performing testing and resolving deviations.
Role type
Senior Quality Assurance Scientist (IVD)
Builds
Reliable IVD products for allergy and autoimmune diagnostics
Domain
In vitro diagnostics, autoimmune diseases, medical technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Enzyme immunoassay (EIA) development and quality control, method validation and transfer, regulatory compliance (FDA/EMA/ISO/ICH), statistical data analysis, GMP/GLP laboratory operations, LIMS usage, corrective and preventive action (CAPA) implementation, SOP development and review
Preferred skills
Chemistry/Biochemistry/Biology/Microbiology degree, project management, technical writing, mentoring staff
Technologies
LIMS, Microsoft Excel
Responsibilities
Perform quality control testing of EIAs, antigens, raw materials, and reagents; provide technical guidance to staff; support product development and LIMS integration; investigate deviations and customer complaints; prepare study reports and SOPs; drive continuous improvement initiatives
Seniority
Senior, hands-on IC
