Qa Specialist Biomarker And Diagnostics, Associate Director
By Bayer At , Cambridge, 02139, Ma
Experience in global vendor/supplier qualification and management, issue investigation/resolution and risk management;
Ensure proper QA issue escalation with senior management and with external vendors;
Strong knowledge of clinical lab certification/accreditation, biomarker assay verification, assay validation, assay transfer, etc;
Extensive experience of CDx/IVD product development under Design Controls and knowledge of QMS design and implementation;
Establish and implement vendor/partner qualification and audit plan with risk-based approach to ensure compliance and proper diligence;
Experience in supporting regulatory submissions (e.g. IDE, 510k, PMA) and HA interactions from QA perspective;
Qa/Training Specialist Jobs
By Conemaugh Health System At , Johnstown, 15905, Pa

SUMMARY: This position is responsible for system integrity for all revenue functions of the EPIC EHR, particularly but not limited to registration, patient account accuracy. This position will be ...