Birgit Krause

Background

About Birgit Krause

Responsible for ensuring Quality System requirements are established and maintained in accordance with applicable government regulations and standards e.g. ISO 13485, FDA 21 CFR 820 QSR, MDD 93/42/EEC, EU MDR, MDSAP • Maintains an efficient quality system by using a risk-based approach and sound decision making • Provides QA support of Engineering, Manufacturing, Installation and Service teams in compliance with ISO 13485, MDSAP and similar standards • Supports Regulatory Affairs regarding regulatory submissions such as 510(k) submissions in the US, CE marking in the EU, etc. • Owns the role of the Person Responsible for Regulatory Compli-ance (PRRC) according to MDR EU 2017/745 • Is the quality system Management Representative according to e.g. ISO 13485:2016 and 21 CFR 820 QSR • Coordinates the forum for conducting management review and col-lects data for review • Manages the overall audit program including internal, supplier, and external audits (e.g. FDA, BSi) of VPS • Manages the overall CAPA and Non-Conformance program at VPS • Works as a cross-functional QA interface towards other Varian loca-tions/sites and business units including PMS activities • Provides organizational leadership to a global Quality team including hiring, development, and training.(6 direct reports; total team size: 19 employees)