Manager Quality Control (m/w/d), EKF - diagnostic GmbH, Barleben
Core
Leading the Quality Control department for In-Vitro-Diagnostic (IVD) products, ensuring conformance of raw materials, intermediates, and finished goods with regulatory standards.
Role type
Senior Quality Control Manager (IVD/Medical Devices)
Builds
IVD diagnostic devices and analyzers
Domain
Medical Devices / In-Vitro-Diagnostic (IVD)
Required skills
Quality Control management, Regulatory compliance (ISO 13485, IVDR), Method validation, LIMS, Trend analysis, Audit management, Team leadership
Preferred skills
FDA 21 CFR Part 820 knowledge, Experience with new analytical techniques
Technologies
LIMS, ISO 13485, IVDR
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 and coordinate 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
