Quality Assurance Manager
Core
Establish and maintain Quality Management System (QMS) processes for the development, manufacture, and analysis of Olink biomarker panels to ensure regulatory compliance and product quality.
Role type
Quality Assurance Manager
Builds
Olink biomarker panels for human protein biomarker discovery
Domain
Life Sciences / Proteomics / Medical Devices
Required skills
QMS process management, material and product quality disposition, non-conformance and complaint management (CAPA), audit management, regulatory compliance (cGMP, ISO 13485/9001, FDA, EMA), cross-functional collaboration
Preferred skills
PPI model implementation, digital systems integration, continuous improvement
Technologies
QMS digital tools
Responsibilities
Own and improve QMS processes, make disposition decisions for materials and products, oversee investigations and root cause analysis, support product development lifecycle, participate in internal and external audits, drive continuous improvement initiatives
Seniority
Manager, hands-on IC
