Manager Quality Control (m/w/d)
Core
Lead the Quality Control department for an IVD manufacturer, ensuring conformance of raw materials, intermediates, and finished goods with regulatory standards.
Role type
Senior IC Quality Control Manager
Builds
IVD blood analysis devices for diabetes, hematology, and veterinary diagnostics
Domain
Medical Devices / In-Vitro-Diagnostics
Required skills
Quality Control management, Regulatory compliance (ISO 13485, IVDR), Method validation, SOP development, Stability study planning, Trend analysis, Team leadership
Preferred skills
LIMS usage, FDA 21 CFR Part 820 knowledge, New analytical technique implementation
Technologies
LIMS
Responsibilities
Lead QC department (labs, incoming inspection, in-process and final control), Ensure conformance of materials and products, Develop and validate testing methods, Create and approve specifications and SOPs, Plan stability studies and ring trials, Conduct trend analysis and handle complaints, Participate in internal and external audits, Lead and develop the QC team
Seniority
Manager, hands-on leadership
